CTO Product Portfolio Occluded anterior tibial artery Tip of Crosser Catheter ® Central lumen vessel recanalization by the Crosser® Catheter The Crosser® Catheter facilitated full central lumen recanalization of the anterior tibial artery CTO Recanalization Frontline Therapy * Enables Central Lumen Crossing * Maximizes Therapeutic Options* Procedural Steps 1 2 Crosser® Catheter advanced over guidewire to CTO 3 Guidewire advanced into distal lumen Crosser Catheter activation ® 4 Therapeutic devices delivered over existing guidewire Focused Efficiency Efficiency The small Crosser® Catheter S6 tip focuses vibrational energy providing greater efficiency 1 2 Flexibility* Improved flexibility of Crosser® Catheter S6 facilitates deliverability to small and tortuous vessels 3 *Bench top data on file. 4 S Support Catheter ® Enhanced Crosser Catheter Deliverability ® Support Stainless Steel, Braided Shaft Construction For greater catheter push and torquability Steerability Angled Tip Configuration Enhanced angle retention to steer the Crosser® Catheter tip towards flush occlusions or lesions on an angle Straight Straight Tapered Angled Angled Tapered Straight Tapered Angled Tapered Low Profile Efficiency Steerability* Usher® Angled Tip Support Catheter provides improved steerability and directability of the Crosser® Catheter to assist with central lumen crossing Smooth Transition Offers a low profile tip to Crosser® S6 Catheter transition to facilitate crossing CTOs *Bench top data on file. Injector Control, Convenience, Integration Control • Single foot switch activates FlowMate® Injector and Crosser® Generator • Physician controls procedure and pace Convenience • Fixed injector settings • Single-operator control Crosser® Generator System Integration • Single IV pole houses FlowMate® Injector and Crosser® Generator • Precise activation and saline delivery optimizes Crosser® Catheter performance Indications For Use The FlowMate® Injector is indicated for use as a sterile saline injector for use as an accessory to the Crosser® Recanalization System. Flowmate Injector Settings (pre-set) Flow Rate: 18 ml/min (0.3ml/sec) Pressure: 200 PSI (13.8 Bar) Volume: 20 ml Rise/Fall: 0 seconds Delay: 0 seconds Injection:Multi Scan with a Smart Phone and your local Bard Rep will contact you. Ordering Information Adjunctive Devices Peripheral – Crosser® CTO Recanalization Catheters Description Crosser® Catheter S6 Item Number Length Platform 106 cm no wire CRES6106 154 cm no wire CRES6 106 cm Crosser® Catheter 14P 146 cm 106 cm Crosser® Catheter 14S 146 cm RX Length 70 cm CREP106 OTW CREOP106 RX CRE14P OTW CREO14P RX CRES106 OTW 110 cm CREOS106 RX CRE14S OTW CREO14S Item Number Crosser Generator – System Electronics ® GEN200 FlowMate® Injector INJ100 Shape Item Number Straight SD70 Straight Tapered SD70T Angled SD70A Angled Tapered SD70AT Straight SD110 Straight Tapered SD110T Angled SD110A Angled Tapered SD110AT Usher® Support Catheters For use with Crosser® Peripheral CTO Recanalization Catheters S6 Length Crosser® Generator / Flowmate® Injector Product Name Sidekick® Support Catheters For use with Crosser® Peripheral CTO Recanalization Catheters 14P and 14S 83 cm 130 cm Shape Item Number Tapered USH83T Angled Tapered USH83AT Tapered USH130T Angled Tapered USH130AT FlowMate® Injector is intended for use with the Crosser® Generator. Recommended Accessories Devices Sidekick® Support Catheter: Crosser® Catheter 14P & 14S Usher® Support Catheter: Crosser® Catheter S6 ATK Crosser® Catheter S6 Usher® Support Catheters All Regions & Highly Calcified Lesions POP Crosser® Catheter 14S (OTW & RX) Sidekick® Support Catheters ATK & POP Regions • ATK • POP • BTK Crosser® Catheter 14P (OTW & RX) Sidekick® Support Catheters BTK POP & BTK Regions Crosser® CTO Recanalization Catheter Indications: The Crosser® Catheter is indicated to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions, including chronic total infrainguinal occlusions. The Crosser® Catheter is only intended for use with the Crosser® Generator. Refer to the Crosser® Generator Manual of Operations for proper use. Contraindications: None known. Warnings and Precautions: 1) The Crosser® Recanalization System should only be used by individuals trained in percutaneous transluminal angioplasty (PTA or PTCA). 2) Prior to use, the packaging and product should be inspected for signs of damage. Never use damaged product or product from a damaged package. 3) DO NOT activate the Crosser® Recanalization System without proper irrigation. Make sure to establish proper irrigation prior to introduction into guide catheter. Always use REFRIGERATED SALINE. 4) The Crosser® Recanalization System should be used in conjunction with proper anticoagulation agents. 5) Never advance or withdraw the Crosser® Catheter without proper fluoroscopic guidance. 6) It is not recommended to use the Crosser® Catheter over guidewires with polymer-jacketed distal ends. 7) Do not exceed 5 minutes of activation time as Crosser® Catheter malfunction may occur. If 5 minutes of activation time is achieved, exchange for a second Crosser® Catheter before resetting the Crosser® Generator. 8) When manipulating the Crosser® Catheter, the Catheter shaft may become warm to the touch. A warm feeling is normal, however, if the Catheter shaft becomes hot discontinue use immediately and withdraw from patient. Once removed from the patient confirm that irrigation is flowing. 9) When using the Crosser® Catheter in tortuous anatomy, the use of a support catheter is recommended to prevent kinking or prolapse of the Crosser® Catheter tip. Kinking or prolapse of the tip could cause catheter breakage and/or malfunction. 10) When using the Crosser® Catheter 14S or 14P with the MicroSheath® XL Support Catheter Tapered, the Crosser® Catheter can be advanced approximately 15 cm from the tip of the support catheter before resistance is encountered due to the taper on the Crosser® Catheter aligning with the taper on the support catheter. A taper lock-up marker (single marker on the Crosser® Catheter shaft) is located 127 cm from the distal tip for the 146 cm Crosser® Catheter and 87 cm from the distal tip for the 106 cm Crosser® Catheter. The taper lock-up marker can be used as an indicator that the tapers on the catheters are nearing alignment; advance the Crosser® Catheter slowly. Do not continue to advance the Crosser® Catheter if resistance is encountered. 11) Position Foot Switch and cable to minimize potential tripping hazard. 12) Ensure Crosser® Generator is securely mounted to IV pole to reduce risk of falling. 13) Should high frequency vibration fail to stop when foot switch is released, power off Crosser® Generator or unplug from power receptacle. 14) Never activate the Crosser® Generator without a Crosser® Catheter attached to the Transducer. 15) The Crosser® Catheter is designed and intended for single patient use only. 16) Store in a cool, dry, dark place. Rotate inventory so that the catheters and other dated products are used prior to the “Use By” date. 17) This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. 18) Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes. 19) After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations. Potential Adverse Events: As with most percutaneous interventions, potential adverse effects include: • Bleeding which may require transfusion or surgical intervention • Hematoma • Perforation • Dissection • Guidewire entrapment and/or fracture • Hypertension / Hypotension • Infection or fever • Allergic reaction • Pseudoaneurysm or fistula Aneurysm • Acute reclosure • Thrombosis • Ischemic events • Distal embolization • Excessive contrast load resulting in renal insufficiency or failure • Excessive exposure to radiation • Stroke/CVA • Restenosis • Repeat catheterization / angioplasty • Peripheral artery bypass • Amputation • Death or other bleeding complications at access site. Warnings and Precautions: 1) The Crosser® Recanalization System should only be used by individuals trained in percutaneous transluminal angioplasty (PTA or PTCA). 2) Warning: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 3) Warning: No modification of this equipment is allowed. 4) Warning: Risk of injury or death to operator or patient can result from unauthorized modification to Crosser® Generator. 5) Note: Position Crosser® Generator to allow easy access to separable power cord during use. 6) Prior to use, the Crosser® Generator, Foot Switch and Transducer should be inspected for signs of damage. Never use damaged components. Contact manufacturer for a replacement. 7) The Crosser® Generator is not protected against the ingress of fluids (IPX0). Do not place fluids above or on the Crosser® Generator as damage to the Crosser® Generator or shock may result. 8) Explosion Hazard: Do not use in the presence of flammable anesthetics. 9) Electrical Shock Hazard: Do not attempt to service Crosser® Generator, Foot Switch or Transducer. Contact manufacturer for servicing requirements. 10) In the event of a power outage, power interruption, or system reset, replace Crosser® Catheter before restarting recanalization procedure. 11) This device generates, uses, and can radiate radio frequency energy and should only be used and installed according to these instructions for use. 12) DO NOT activate the Crosser® Recanalization System without proper irrigation. Make sure to establish proper irrigation prior to introduction into guide catheter. 13) Do not exceed 5 minutes of activation time as Crosser® Catheter malfunction may occur. If the 5 minutes of activation time is achieved, exchange the device for a new Crosser® Catheter before resetting the Crosser® Generator. 14) Position Foot Switch and cable to minimize potential tripping hazard. 15) Ensure Crosser® Generator is securely mounted to a 5 caster IV pole with minimum caster diameter of 7.62cm (3 inches) and a minimum base diameter of 55.9cm (22 inches) no higher than 1.5 meters off the ground. 16) Should high frequency vibration fail to stop when Foot Switch is released, power Crosser® Generator ‘OFF’ or unplug from power receptacle. 17) Keep out of reach of patients. The Crosser® Generator must be at least 1.5 meters away from the patient. Caution! The unit is equipped with an exhaust vent. Do not block the openings or internal heat build-up may occur, causing heat build-up or damage to the equipment. Crosser® Generator Sidekick® and Usher® Support Catheters Indications: The Crosser® Recanalization System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions. The Crosser® Generator is intended for use only with the Crosser® Catheter. Refer to the Crosser® Catheter Instructions for Use. Indications: The Sidekick® and Usher® Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. Flowmate® Injector Indications: The Flowmate® Injector is indicated for use as a sterile saline injector for use as an accessory to the Crosser® Recanalization System. Refer to the Crosser® Generator and the Crosser® Catheter Instructions for Use for complete system operation and interventional use procedure. Warnings and Precautions: 1) The Flowmate® Injector should only be used by individuals trained in percutaneous transluminal angioplasty (PTA or PTCA). 2) Prior to use, the Flowmate® Injector, Foot Switch and all connection to power and the Crosser® Generator should be inspected for signs of damage. Never use damaged components. Contact the manufacturer for a replacement or servicing. 3) The Flowmate® Injector is intended to be used with sterile normal saline only. Do not use the Flowmate® Injector with contrast media. 4) Explosion Hazard: Do not use in the presence of flammable anesthetics. 5) Electrical Shock Hazard: Do not attempt to service Flowmate® Injector or Foot Switch. Contact manufacturer for servicing requirements. 6) The Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked Hospital Only or Hospital Grade. Grounding reliability cannot be achieved by connecting the system to a Multiple Portable Socket-Outlets (MPSO – power strip) or extension cord. 7) In the event of a power outage or power interruption, run through the set-up procedures. The Flowmate® Injector is designed to prevent operation following such events until the set-up procedures are repeated. 8) This Flowmate® Injector generates, uses, and can radiate radio frequency energy and should only be used and installed according to these instructions for use. 9) Position Foot Switch and cable to minimize potential tripping hazard. 10) Ensure Flowmate® Injector is securely mounted to a 5 caster IV pole no higher than 1.3 meters (51 inches) off the ground. The Flowmate® Injector should not be mounted above the Crosser® Generator. 11) Should high frequency vibration or saline infusion fail to stop when Foot Switch is released, power Flowmate® Injector/ Crosser® Generator ‘OFF’ or unplug from power receptacle. 12) Do not reuse disposable items. Dispose of per normal hospital procedures. 13) Air Embolism Risk: to minimize air embolism risk, make certain the operator is trained on proper syringe loading techniques. Before injecting, be sure to clear air trapped in the syringe, infusion line and the Crosser® Catheter. Do not introduce the Crosser® Catheter into the patient until all air has been purged from the infusion line and the Crosser® Catheter. A steady stream of saline exiting from the tip of the Crosser® Catheter will be observed once all air has been purged. Contraindications: The Sidekick® and Usher® Catheters are contraindicated for use with cutting/scoring balloons, pediatrics, neonatal and neurovascular patients. Warnings: 1) Contents are supplied STERILE, using ethylene oxide (EO), and Non Pyrogenic. Do not use if sterile barrier is opened or damaged. 2) This device has been designed for single patient use only. Reusing this medical device bears the risk of cross patient contamination as medical devices, particularly those with long and small lumina, joints, and/or crevices between components are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications. 3) Do not reuse, reprocess or resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes. 4) When the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation. Movement of the product without fluoroscopic guidance may result in damage to the product or vasculature or cause vessel perforation. 5) Manipulating or torquing a product against resistance may cause damage to the product or vasculature or cause vessel perforation. Never advance, withdraw or torque a catheter which meets resistance. 6) Flush the catheter prior to inserting and reinserting the product to prevent air from entering catheter system. 7) After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practices and applicable local, state and federal laws and regulations. 8) Diethylhexylphthalate (DEHP) is a plasticizer used in some polyvinyl chloride medical devices. DEHP has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy. Although the toxic and carcinogenic effects of DEHP have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial. Bard has not assessed any related adverse effects in relation to the exposure to DEHP when this device is used with neonates, infants, pregnant or breast feeding women. It is the responsibility of the physician to assess risks associated with the use of a device containing DEHP. Precautions: 1) Carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. 2) The Sidekick® and Usher® Catheters should only be used by physicians trained in percutaneous intravascular techniques and procedures. 3) Verify compatibility of the product’s inner and outer diameters and lengths with other devices before use. 4) Refer to package label for tip shape for the Sidekick® and Usher® Catheters. Do not attempt to manipulate or re shape the tip configurations. 5) When using a Rotating Hemostatic Valve (RHV) in place of the hemostatic valve provided with the product, do not over tighten the RHV. A tight RHV may damage the Crosser® Catheter. Use extra caution when using a self sealing RHV. 6) Flushing through the sideport of the hemostatic valve is not recommended when the Crosser® Catheter is in place as the infusate may leak from the hemostatic valve. Adverse Effects: Use of the Sidekick® and Usher® catheters may give rise to the following complications: • Hemorrhage, Hematoma, Ischemia • Vessel perforation/dissection • Allergic reaction to contrast medium • Vascular occlusion, thrombosis • Infection • Vessel erosion, spasms • Embolism • Puncture site hematoma, pain and tenderness. Please consult package inserts for more detailed safety information and instructions for use. Bard, Crosser, Flowmate, Sidekick and Usher are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. All other trademarks are the property of their respective owners. © Copyright 2013, C. R. Bard, Inc. All Rights Reserved. S120330 Rev 0 Bard Peripheral Vascular, Inc. 1625 W. 3rd Street Tempe, AZ 85281 USA Tel: 1 480 894 9515 / 1 800 321 4254 Fax: 1 480 966 7062 / 1 800 440 5376 www.bardpv.com
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