9/26/2020
`
`Indications, Safety, and Warnings
`
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`HEALTHCARE STAFF
`GuardWire
`Temporary Occlusion and Aspiration
`System
`
`INDICATIONS, SAFETY, AND WARNINGS
`INDICATIONS AND INTENDED USE
`The GuardWire Temporary Occlusion and Aspiration System is indicated for use in
`the coronary saphenous vein bypass grafts (2.5 - 5.0 mm) to:
`
`Contain and aspirate embolic material (thrombus / debris) while performing
`percutaneous transluminal coronary angioplasty or stenting procedures.
`To subselectively infuse / deliver diagnostic or therapeutic agents with or
`without vessel occlusion.
`The safety and effectiveness of this device as an embolic protection system has
`not been established in the cerebral, carotid or peripheral vasculature.
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`Indications, Safety, and Warnings
`The safety and effectiveness of the device as an embolic protection system has
`not been established in treating patients with acute myocardial infarction.
`The safety and effectiveness of the device as an embolic protection system has
`not been established in treating native coronaries.
`
`The Guardwire 3-6 Temporary Occlusion and Aspiration System is indicated for use
`in the coronary saphenous vein bypass grafts to:
`
`Contain and aspirate embolic material (thrombus / debris) while performing
`percutaneous transluminal coronary angioplasty or stenting procedures
`To subselectively infuse / deliver diagnostic or therapeutic agents with or
`without vessel occlusion
`The safety and effectiveness of this device as an embolic protection system has
`not been established in the cerebral, carotid or peripheral vasculature.
`WARNINGS
`Use of the GuardWire Temporary Occlusion and Aspiration System requires an
`experiential learning curve needed to achieve familiarity with the proper use of
`the device. Prior to using the physician should have completed a training
`program regarding proper use of this device. Please see the Physician Training
`Section for further details.
`Prior to use, the packaging and product should be inspected for signs of
`damage. Never use damaged product or product from a damaged package.
`The GuardWire catheter should be handled carefully. Prior to use and when
`possible during the procedure, inspect the GuardWire catheter carefully for
`bends, kinks, or other damage. Do not use a damaged GuardWire catheter
`because failure to inflate or deflate the balloon, vessel damage and / or
`inaccurate torque response may occur.
`The EZ flator device contains a full range of volume designed exclusively for the
`GuardWire catheter. WHEN INFLATING THE GUARDWIRE BALLOON, USE
`ON THE EZ FLATOR inflation device. Do not over-inflate the GuardWire balloon
`after fully occluding the vessel. THE INFLATION DIAL SHOULD NOT BE
`TURNED GREATER THAN 1 MM BEYOND THE VESSEL SIZE, AS BALLOON
`RUPTURE MAY OCCUR.
`The GuardWire catheter is not recommended for ostial lesion use.
`PRECAUTIONS
`Confirm the compatibility of other devices with the GuardWire catheter before
`actual use.
`Use only with devices that are approved for their intended use.
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`Indications, Safety, and Warnings
`The GuardWire Temporary Occlusion Catheter and accessories should be used
`in conjunction with fluoroscopic guidance and proper anticoagulation agents.
`Use only diluted contrast as the balloon inflation medium 60% contrast diluted
`1:3 with heparinized normal saline or 76% contrast diluted 1:3 (1 part contrast 3
`parts heparinized normal saline). Never use air or any gaseous medium to
`inflate the balloon.
`When using the Export Catheter for fluid delivery, do not exceed the maximum
`flow rate specified for the device (see Table 16 of IFU).
`
`CAUTION: If there is an angle in the saphenous vein graft more acute than 60°
`distal to the target stenosis, the stent placement should stop approximately 10 mm
`before the vessel angle or the stent should extend completely around the angulated
`segment. In the event that resistance is met in removing the deflated GuardWire
`Catheter, a 5Fr straight coronary guide catheter with an inner luminal diameter of
`0.055°/5Fr and a length of >125 cm in length may be advanced over the GuardWire
`Catheter used to encase the deflated occlusion balloon and allow it to be retracted
`slowly through a fully deployed stent and back into the guide catheter for complete
`removal.
`
`The system has been tested to 6 inflation/deflation cycles. Following proper
`preparation, it is NOT recommended that the system be inflated/deflated more
`than 6 times.
`The device is designed and intended for single patient use only. Do NOT
`resterilize and/reuse it.
`Always advance and withdraw the GuardWire Catheter slowly. Never push,
`withdraw or torque a GuardWire Catheter that meets resistance.
`The GuardWire occlusion balloon once inflated should be observed under
`fluoroscopy during catheter exchange to be sure the balloon does not move.
`The GuardWire Catheter should be treated like any standard coronary wire
`during catheter exchanges
`As in any elective coronary intervention, it is recommended that the patient
`have a mean systolic blood pressure greater than or equal to 90 mm Hg in
`concomitant of IV pressors or intra-Aortic Balloon Pump augmentation.
`Use caution when using the GuardWire Temporary Occlusion and Aspiration
`System in conjunction with a Rotating Hemostatic Valve (RHV), which utilizes a
`compression gasket to tighten onto the GuardWire catheter. This type of RHV
`does not rely on a manual tightening, unlike standard RHV’s, and as a result,
`may place additional grip force on the GuardWire catheter such that inadvertent
`movement of the distal occlusion balloon may occur. An RHV of this type is the
`Guidant Copilot™ RHV.
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`Indications, Safety, and Warnings
`Avoid over tightening of wire torquing devices on the GuardWire catheter as it
`may result in damage to the hollow hypotube.
`
`Important Information: Prior to use, refer to the Instructions for Use supplied with
`this device for indications, contraindications, side effects, suggested procedure,
`warnings and precautions.
`
`Caution: Swedish law restrictions this device to be ordered by, and sold to, a
`physician or medical institution only. See package insert for full product information.
`
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`Page 4
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`Teleflex Ex. 2208
`Medtronic v. Teleflex
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