External Drainage and Monitoring Catheters

External Drainage and Monitoring Catheters
Description
EDM Ventricular Catheters, Barium Impregnated
Becker® EDMS Ventricular Catheter, 20cm and EDM Ventricular Catheter, 35cm with Trocar products are fabricated
from silicone elastomer tubing impregnated with barium sulfate to provide radiopacity. Relatively firm tubing
is incorporated in the catheter design to provide resistance to catheter kinking and compression. The tip of the
catheter is bullet shaped and is filled with radiopaque, tantalum-impregnated silicone elastomer. Black length
markers made of graphite-impregnated silicone elastomer are positioned on the catheter at points 5, 10 and 15cm
from the proximal tip to enable the surgeon to gauge the depth of penetration of the catheter into the lateral
ventricle.
A stainless steel stylet, packaged with each catheter, is designed to facilitate introduction of the catheter into the
lateral ventricle. The catheter is packaged with the stylet inserted in the lumen.
Becker EDMS Ventricular Catheter, 20cm, Barium Impregnated
This device consists of a barium-impregnated silicone elastomer ventricular catheter, 20cm in length, with black
length markers (at 5, 10 and 15cm from proximal tip), a luerlock connector and a stainless steel stylet to facilitate
placement of the catheter in the lateral ventricle. The luerlock connector includes a plug to facilitate its closure
prior to connection to other drainage or monitoring system components.
EDM Ventricular Catheter, 35cm, Barium Impregnated with Trocar
This device consists of a barium-impregnated silicone elastomer ventricular catheter 35cm in length with black
length markers (at 5, 10 and 15cm from proximal tip), a luerlock connector, a red end plug, a silicone elastomer
fixation collar, a stainless steel stylet and a stainless steel trocar.
Indications
The EDM Ventricular Catheters are designed for use as the proximal component for cerebrospinal fluid (CSF)
drainage and/or monitoring from the lateral ventricles of the brain.
Instructions for Use
A variety of surgical techniques may be used in placing the catheters into the lateral ventricle. The site of
placement and techniques used are at the discretion of the surgeon.
CAUTION: LOW TEAR STRENGTH IS A CHARACTERISTIC OF MOST UNREINFORCED SILICONE ELASTOMER
MATERIALS. CARE MUST BE TAKEN WITH THE HANDLING AND PLACEMENT OF THE SILICONE ELASTOMER
CATHETER TUBING TO AVOID CUTS, NICKS OR TEARS.
Surgical Technique – Ventricular Catheter
The following surgical technique for placement of the ventricular catheter has been provided by Dr. Donald P.
Becker and his staff.
Prior to surgery, the balance of the drainage and/or monitoring system should be completely assembled in
operational condition. The preoperative preparation of the patient is carried out with the standards of care
appropriate for an intracranial operation. A broad-spectrum antibiotic is administered preoperatively and
continued during the 24-hour postoperative period.
The head is completely shaved, cleaned and prepared in a manner appropriate for craniotomy. Using local
anesthesia, a 2.5cm parasagittal incision is made just anterior to the right coronal suture in line with the medial
margin of the iris. A self-retaining retractor is inserted and the skull is exposed by retracting the periosteum.
A twist drill hole directed slightly mesially is made with a 9/64” bit. Under ideal conditions, the twist drill should
penetrate the dura without injuring the underlying brain. The dura may also be opened with a #11 surgical blade.
With the stylet in place, the tip of the ventricular catheter can be directed from the twist drill hole in the following
ways:
1) toward the inner canthus of the ipsilateral eye;
2) in a plane aligned 2cm anterior to the external auditory canal in the coronal plane;
3) toward the bridge of the nose; or
4) toward the inner canthus of the contralateral eye.
If the ipsilateral ventricle is not entered, the physician may choose to attempt insertion of the ventricular catheter
from the opposite side of the patient’s skull. Should this also fail, the surgeon may consider the alternative of
monitoring with a subarachnoid bolt (e.g., Richmond Bolt).
The relative markers for the incision site and direction for catheter insertion are illustrated in Figures 1a-b.
If a subarachnoid bolt is to be used, then placing the bolt
in a new twist drill hole—to decrease the possibility of
1a
1b
clogging of the subarachnoid bolt with brain tissue—is
recommended.
When the ventricle is entered, the stylet is withdrawn
and the catheter is occluded at the scalp level by pinching
with an appropriate clamp. Only a minimal amount of
CSF should be permitted to escape. This is particularly
important if the ICP is not elevated.
CAUTION: OVERDRAINING MAY PREDISPOSE TO VENTRICULAR COLLAPSE, AND POTENTIALLY SUBSTANTIAL
PATIENT INJURY.
The distal end of the occluded catheter is now tunneled under the scalp to emerge through a stab wound placed
posterior to the ventriculostomy incision.
The EDM Ventricular Catheter, 35cm, includes a trocar which may be used to facilitate this placement. The trocar
may be inserted into the distal end of the catheter for attachment. After desired placement of the catheter, cut
the distal end of the catheter to detach the trocar.
The enclosed luerlock adapter may now be inserted into the catheter and attached to other components of the
drainage and/or monitoring system. Specific details regarding catheter connection are found in the Instructions
for Use for the PS Medical Becker EDMS and PS Medical EDM Kits.
Secure the catheter to the connector with a double suture tie using
2
0 silk suture (Fig 2).
Care should be taken to ensure that the catheter and the balance of
the drainage and/or monitoring system is filled and devoid of any
air bubbles. If the catheter is properly
placed, a satisfactory waveform
3a
3. Fixation Collar
2. Suture
should be visible on the monitoring
equipment. Minor adjustments of the
ventricular catheter position may be
1. To Patient
necessary to accomplish this.
Monitoring
4. Luerlock Connector
5. Catheter
After a satisfactory waveform is
System
obtained, the ventriculostomy wound
is closed with interrupted sutures and a 3b
6. Suture Hole
full head dressing applied.
A silicone fixation collar may be
applied prior to completing the full
head dressing. Spread open the collar
(Fig 3a) and position the catheter inside
the groove within the collar (Fig 3b).
7. Scalp
3c
Then, secure the fixation collar to the
scalp by passing a ligature through the
two holes in the flange of the fixation
collar (Fig 3c).
8. Catheter
2. Suture
Description
Exit Site
EDM Lumbar Catheters,
Barium Impregnated
EDM Lumbar Catheter, 24cm and EDM Lumbar Catheter, 80cm products are fabricated from silicone elastomer
tubing impregnated with barium sulfate to provide radiopacity. Relatively firm tubing is incorporated in the
catheter to provide resistance to kinking and compression. The open lumbar tips of the EDM Lumbar Catheter,
24cm and EDM Lumbar Catheter, Open Tip,
80cm, are trimmed at an angle (Fig 4). The
4
lumbar tip of the EDM Lumbar Catheter, Closed
Tip, 80cm is bullet-shaped and filled with
radiopaque tantalum impregnated silicone
elastomer (Fig 5). A PTFE-coated stainless steel
5
guidewire with adjustable stop is provided
with the Closed Tip 80cm EDM Llumbar
Catheter to facilitate placement. All catheters
have multiple inlet holes located within approximately 17 mm of the lumbar tip. Length markers of graphite
impregnated silicone elastomer are positioned on the catheters at points 11, 16 and 21cm from the lumbar tip (an
additional 26cm length marker is included on the 80cm EDM Lumbar Catheters).
When the 11cm marker is aligned with the slot opening in the hub of the provided Tuohy needle, the tip of the
catheter is aligned with the tip of the needle.
The lumbar catheter design, guidewire with adjustable stop (if included), and the 14-gauge Tuohy needle allow
for percutaneous placement without need for laminectomy.
Separate silicone elastomer fixation tabs are included to anchor the catheter as required. All EDM Lumbar
Catheters include a luer connector with cap and a silicone elastomer strain relief sleeve.
Indications
The EDM Lumbar Catheters are designed for use as the proximal component for CSF drainage and/or monitoring
from the lumbar subarachnoid space.
Instructions for Use
A variety of surgical techniques may be used in placing the catheters into the lumbar subarachnoid space. The site
of placement and technique used are at the discretion of the surgeon.
Surgical Technique — EDM Lumbar Catheter
The use of local or general anesthesia during the placement of the catheter is at the discretion of the surgeon.
Catheter patency prior to implantation should be verified by gently flushing sterile saline solution through the
catheter. A 20-gauge blunt needle adapter is provided with the EDM Lumbar Catheters, 80cm for this purpose. It
may be placed into the open end of the catheter to facilitate flushing.
NOTE: Refer to the “Guidewire and Adjustable Stop” section for
instructions on proper guidewire use during catheter implantation 6
(EDM Lumbar Catheter, 80cm Closed Tip only).
Position the patient on one side with partial hip and knee flexion
(Fig 6). Prepare and drape the surgical areas (low back) as a sterile
field.
Make a 2cm incision between the spinous processes of L4-L5 or
L5-S1. Elevate the patient’s head about 30° to increase intraspinal
6
CSF pressure. Insert the 14-gauge Tuohy needle with the bevel
cephalad, and advance into the lumbar subarachnoid space.
Withdraw the needle stylet and lower the patient’s head when a free flow of CSF is obtained. Introduce the
lumbar catheter through the Tuohy needle. Insert 8cm of catheter into the subarachnoid space cephalad to the
puncture site. Slowly remove the guidewire, if used. Slowly remove the Tuohy needle, leaving the catheter in
place. Secure the catheter with fixation tab(s).
Proper catheter placement in the lumbar subarachnoid space should be verified. This is verified by the flow of CSF
from the catheter or through the use of appropriate imaging techniques. Occlude catheter with an appropriate
clamp or finger pressure to ensure that as little CSF as possible is lost. Proper catheter placement allows lumbar
subarachnoid drainage and pressure monitoring.
CAUTION: TO AVOID POSSIBLE TRANSECTION OF THE CATHETER, THE CATHETER SHOULD NEVER BE
WITHDRAWN THROUGH THE TUOHY NEEDLE. IF THE CATHETER NEEDS TO BE WITHDRAWN, THE TUOHY
NEEDLE AND CATHETER (WITH GUIDEWIRE, IF USED) MUST BE REMOVED SIMULTANEOUSLY.
Silicone elastomer fixation tabs are provided to anchor
7b
7a
the catheter at the incision site, as desired. The tabs wrap
around the catheter and can be located at any point. The
fixation tabs are applied to the catheter by spreading them
open and positioning the catheter in the fixation tab groove
(Fig 7a). The tabs are then closed (Fig 7b). To secure the
fixation tab to the catheter, a suture is passed through the
two holes in the tab and tied. The tabs are then sutured to
the exposed fascia at the lumbar incision. The catheter is left externalized at this point.
Using the Lumbar Catheter Strain Relief
The Lumbar Catheter Strain Relief is fabricated from
translucent silicone elastomer and is designed to fit
securely over a luerlock connector. The Strain Relief is used
with PS Medical Lumbar Catheters to provide support to
and lessen the potential of catheter kinking at the luerlock
connector junction.
Slide the short translucent Strain Relief onto the external
end of the catheter narrow end first (Fig 8a), so that the
flared end of the Strain Relief is directed towards the end of
the catheter. The luerlock connector may now be inserted
into the catheter. Slide the short translucent Strain Relief
over the luerlock connector (Fig 8b) and verify that the
catheter/connector junction is intact. Secure the strain
relief and catheter to the connector with a tight suture tie
in the groove of the strain relief, using 0 silk suture (Fig 8c).
The plug attached to the luerlock connector may be used to
prevent loss of CSF prior to attachment of the catheter to the
patient line of the drainage system.
8a
4. Luerlock
Connector
10. Luerlock Cap
9. Strain
Relief
5. Catheter
8b
8c
Guidewire and Adjustable Stop
2. Suture
A PTFE-coated stainless steel guidewire with adjustable
stop is provided with the PS Medical EDM Lumbar Catheter,
80cm, Closed Tip, to increase the maneuverability of the
silicone catheter.
To use the adjustable stop, loosen the luer cap. Partly
withdraw the guidewire from the dispenser. Pass the flexible tip of the guidewire through the luer fitting of the
adjustable stop, out the rounded end, and into the connector end of the lumbar catheter. Thread the guidewire
through the connector end of the catheter so that the guidewire contacts the filled tip of the lumbar catheter.
Slide the adjustable stop so that the rounded end is touching the connector end of the catheter. Tighten the cap to
affix the adjustable stop to the guidewire. Discard the guidewire dispenser.
Connection of Catheter to Drainage and/or Monitoring System
Using the included luerlock connector, the PS Medical EDM Lumbar Catheter may be directly attached to a PS
Medical Becker EDMS or PS Medical EDM Drainage Assembly.
NOTE: There is slight resistance to flow caused by the lumbar drainage catheter. The average resistance to flow at
a constant flow rate of 23 mL/hour is 0.1cm H2O per cm of catheter length. This resistance to flow may result in a
reduction of system pressure as compared with actual in vivo pressure.
Needleless Injection Site
The Interlink® injection site is single use only. Do not resterilize.
1. Swab septum of injection site with antiseptic prior to access.
2. Access Interlink injection site (identified by a colored ring) with Interlink cannula (not supplied).
3. Replace every 24 hours or per institutional protocol.
This product does not contain natural rubber latex.
CAUTION: IF NEEDLE MUST BE USED, INSERT SMALL GAUGE NEEDLE INTO PERIMETER OF SEPTUM.
CAUTION: DO NOT DISCONNECT ADMINISTRATION SET, SYRINGE OR OTHER COMPONENT FROM CANNULA
WHILE CANNULA IS STILL CONNECTED TO INTERLINK INJECTION SITE.
How Supplied
EDM Ventricular and Lumbar Catheters; Needleless Injection Site
The EDM ventricular and lumbar catheters are supplied as individual products, sterile and non-pyrogenic in
double wrap packages. The Interlink injection site is provided sterile. These products are designed for single
patient use only. Do not re-use, re-process, or re-sterilize this product. Re-use, re-processing or re-sterilization
may compromise the structural integrity of the device and/or create a risk of contamination of the device, which
could result in patient injury, illness, or death. Medtronic Neurosurgery is not responsible for the performance of
any product which has been resterilized.
Special Order Products
If this Instructions for Use accompanies a special order product, there will possibly be differences in the physical
characteristics between the product enclosed and the product description in this product package insert. These
differences will not affect the safety or efficacy of the special order product.
Special order products may be supplied sterile or non-sterile as indicated on the product package label. Nonsterile products must be cleaned and sterilized prior to use.
Patient Education
It is the physician’s responsibility to educate the patient and/or their representative(s) regarding external
drainage and monitoring. This should include a description of associated complications, and an explanation of
potential alternative products and treatments.
Contraindications
Intracranial pressure monitoring with a ventricular or lumbar catheter is contraindicated in patients receiving
anticoagulants or who are known to have a bleeding diathesis. The ventricular catheter is contraindicated if scalp
infection is present. A patient undergoing external drainage and monitoring must be kept under continuous,
close supervision. The use of a ventricular or lumbar drainage catheter is contraindicated where trained personnel
are not available to supervise monitoring and drainage on a 24-hour-a-day basis.
The use of a lumbar catheter for drainage and monitoring of cerebrospinal fluid is not recommended for patients
with non-communicating hydrocephalus; where lumbar puncture is contraindicated; in the presence of large
intracranial mass lesions, tumors, hematomas or cysts; in the presence of infections in the surrounding area which
includes the skin, subcutaneous tissue, bone and the epidural space; and in patients which have demonstrated
blockage of cerebrospinal fluid to the subarachnoid space due to trauma, hematoma, fracture or tumor. The
use of a lumbar catheter under these conditions for external drainage and monitoring is at the discretion of the
physician.
Monitoring pressure from the lumbar subarachnoid space can be done only in instances where lumbar puncture
does not pose a danger to the patient.
Warnings and Precautions
It is the responsibility of the physician to describe and explain the following warnings, precautions and
complications to the patient and/or his representatives prior to proceeding with any surgical procedures.
Failure to appropriately adjust the rate of CSF outflow through the external drainage system may result in
potentially serious injury to the patient.
Lint, fingerprints, talc and other surface contaminants or residues from latex gloves can cause foreign body or
allergic reactions.
Improper use of instruments in handling or implanting EDM Catheter products may result in the cutting, slitting,
breakage or crushing of components. Such damage may lead to a loss of system integrity, and necessitate surgical
revision or removal of the system.
Patients undergoing external drainage and/or pressure monitoring must be constantly supervised on a 24-houra-day basis for signs and symptoms of overdrainage or underdrainage. Inadequate vigilance or improper drainage
system setup can lead to serious injury to the patient.
Patients must be isolated from external drainage systems, by adjustment of the stopcock, prior to being moved
or repositioned. See EDM Kits or Becker EDMS Instructions for Use booklets for stopcock adjustment instructions.
After any movement or repositioning, it is imperative that the height of the external drainage system is verified
for accuracy to the patient’s new position. Failure to ensure correct positioning of the external drainage system
can lead to overdrainage or underdrainage, and potentially serious injury to the patient.
Care must be taken to prevent complete or partial catheter pullout during patient movement or repositioning.
Care must be taken to ensure that particulate contaminants are not introduced into components during
implantation, testing or handling. This could result in improper performance of the system.
In securing the ventricular catheter to the luerlock connector, the ligature encircling the catheter should be
securely, but not too tightly, fastened lest it eventually cut through the silicone tubing.
Care must be taken in the routing of catheters to prevent kinking and needless abrasion along their course.
A suture tie with 0 silk suture should be used to secure the strain relief to the luerlock connector/catheter junction.
Check to ensure that the connection is secure prior to use.
When the cerebral ventricles or lumbar subdural space are first punctured during the insertion of the catheter,
care should be taken to ensure that as little CSF as possible is lost.
Care must be taken during the placement of the catheter into the lumbar subarachnoid space to ensure that the
catheter is properly located.
To avoid transection of the lumbar catheter during catheter placement, the catheter should never be withdrawn
through the Tuohy needle. If the catheter needs to be withdrawn, the needle, guidewire and the catheter must be
removed simultaneously.
EDM Catheters should be removed if the patient develops signs of meningeal irritation or if there is suspicion of
contamination or infection in the operative site or anywhere along the subcutaneous device.
Separation of EDM Catheter components due to disconnection or catheter fracture has been reported.
Complications
The major complication associated with ICP monitoring with a ventricular or lumbar catheter is the risk of
infection, particularly meningitis and ventriculitis. The incidence of these infections can be reduced by care in
inserting the ventricular catheter and stabilizing it by passing it through a subgaleal tunnel before it emerges.
The lumbar catheter should be stabilized by use of fixation tabs. Wound infections may occur but usually subside
when the catheter is removed.
Limiting the duration of monitoring from a single site to less than five days will reduce the infection rate. If
monitoring must continue past five days, it is recommended that a new catheter be inserted at a fresh site, and
the entire system be changed.
Inadequate patient monitoring of intracranial pressure and CSF drainage may result in temporary or permanent
brain damage.
Frequent punctures of the brain to insert the ventricular catheter can predispose to intracerebral hemorrhage and
edema causing a further rise in ICP, and can result in permanent damage to the cerebral tissue. This can result in a
loss of sensory or motor functions of the patient.
Poor recording of ICP will result if the catheter, patient line or other components of the monitoring system
become clogged with blood clots, brain tissue fragments or fibrinous debris.
In patients with small ventricles, the ventricular walls may collapse around the tip of the catheter resulting in
obstruction and predisposing to tentorial herniation. It is therefore extremely important to avoid excessive
release of CSF before or after the catheter is attached to the drainage system.
Instructions for Use
Returned Goods Policy
Products must be returned in unopened packages, with manufacturer’s seals intact, to be accepted for
replacement or credit, unless returned due to a complaint of product defect or mislabeling.
Determination of a product defect or mislabeling will be made by Medtronic Neurosurgery, which determination will
be final.
Products will not be accepted for replacement or credit if they have been in possession of the customer for more
than 90 days.
External Drainage & Monitoring Catheters
Warranty
A. Standard Limited Warranty. Medtronic Neurosurgery warrants to the original end user purchaser
(“Purchaser”) that the enclosed single use product (“Product”) purchased by Purchaser, at the time of delivery to
Purchaser, shall be substantially free from defects in material and workmanship. Medtronic Neurosurgery makes
no warranty (express, implied or statutory) for Products that are modified (except as expressly contemplated
herein) or subjected to unusual physical stress, misuse, improper operation, neglect, improper testing, use in
combination with other products or components other than those for which the Products were designed, or use in
any manner or medical procedure for which the Products are not indicated.
B. Remedy. Purchaser’s exclusive remedy and Medtronic Neurosurgery’s sole liability for breach of the foregoing
warranty shall be, at Medtronic Neurosurgery’s sole option and election, to replace the Product or credit
Purchaser for the net amount actually paid for any such Product; provided that (i) Medtronic Neurosurgery is
notified in writing within ninety (90) days after Purchaser’s receipt of the Product that such Product failed to
conform, including a detailed explanation in English of any alleged nonconformity; (ii) such Product is returned
to Medtronic Neurosurgery within ninety (90) days after Purchaser’s receipt of the Product F.O.B. 125 Cremona
Drive, Goleta, California 93117, U.S.A. or as otherwise designated by Medtronic Neurosurgery; and (iii) Medtronic
Neurosurgery is reasonably satisfied that the claimed nonconformities actually exist. Except as expressly provided
in this paragraph, Purchaser shall not have the right to return Products to Medtronic Neurosurgery without
Medtronic Neurosurgery’s prior written consent.
C. Exclusion of Other Warranties. EXCEPT FOR THE LIMITED WARRANTY PROVIDED IN (A) ABOVE,
MEDTRONIC NEUROSURGERY GRANTS NO OTHER WARRANTIES OR CONDITIONS, EXPRESS OR IMPLIED
AND MANUFACTURER SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES AND CONDITIONS OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC NEUROSURGERY NEITHER
ASSUMES NOR AUTHORIZES ANY OTHER PERSON TO ASSUME ANY OTHER LIABILITIES ARISING OUT OF OR
IN CONNECTION WITH THE SALE OR USE OF ANY PRODUCT.
Caution: Consult Accompanying Documents
Sterilization: Ethylene-Oxide Gas
Use by
Package Contents
Do Not Reuse
Reference Number
Lot Number
Caution: For U.S. audiences only.
Caution: U. S. federal law restricts this device to sale by or on the order of a physician.
Manufacturer
Becker® and PS Medical® are registered trademarks of Medtronic, Inc.
EDM Ventricular Catheter, Barium Impregnated
Becker EDMS Ventricular Catheter, 20cm, Barium Impregnated
EDM Ventricular Catheter, 35cm, Barium Impregnated with Trocar
Medtronic, Inc.
710 Medtronic Parkway NE
Minneapolis, MN 55432-5604 USA
Design Facility:
Medtronic Neurosurgery
125 Cremona Drive
Goleta, California 93117-5500 USA
(800) 468-9710 USA/Canada
(805) 344-0645 International
(800) 468-9713 FAX USA/Canada
(901) 396-2698 FAX International
17556COM-1A 24662
© Medtronic, Inc. 2009
All Rights Reserved
Printed in USA

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