INDICATIONS, SAFETY, AND WARNINGS Export™ AP Aspiration Catheter

IMPORTANT INFORMATION

Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions.

The Export™ AP Aspiration Catheter is Indicated for:

• Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
• To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.

WARNINGS

• If the Export catheter is to be used with the GuardWire Temporary Occlusion and Aspiration System, consult the GuardWire Temporary Occlusion and Aspiration System IFU prior to use.
• Prior to use, the packaging and product should be inspected for signs of damage. Never use damaged product or product from a damaged package.
• Do not attempt to advance or retract the Export catheter against resistance until the cause of resistance has been determined by fluoroscopy or other means. Maintain visualization of the length of the wire while using the Export catheter, specifically in the region distal to the guide catheter and proximal to the Export catheter marker band. Should a loop or excessive slack in the wire be visualized, do not attempt to retract the Export catheter into the guide catheter until the loop or excessive slack is eliminated. Retracting the Export catheter without straightening the wire may potentially tear the wire lumen, which could cause dislodgement of the marker band into the vasculature.
• The Export catheter should be handled carefully. Prior to use, inspect the Export catheter carefully for bends, kinks, or other damage. Do not use a damaged Export catheter.

PRECAUTIONS

• The Export catheter and accessories should be used in conjunction with fluoroscopic guidance and proper anticoagulation agents.
• When using the Export catheter for fluid delivery, do not exceed the maximum flow rate specified for the device (see Table 1).
• This device is designed and intended for single patient use only. DO NOT resterilize and/or reuse it.
• As in any elective coronary intervention, it is recommended that the patient has a mean systolic blood pressure greater than or equal to 90 mm Hg in concomitant of IV pressors or intra-aortic balloon pump augmentation.

ADVERSE EFFECTS

As with most percutaneous interventions, other potential adverse events include: death, myocardial infarction, coronary or bypass graft thrombosis or occlusion, myocardial ischemia, stroke/CVA, emergent or non-emergent bypass graft surgery, emboli (air, tissue or thrombotic), dissection, arterial perforation, arterial rupture, ventricular fibrillation, hemorrhage, hypotension, pseudoaneurysm at access site, arteriovenous fistula, infection at access site, other bleeding complications at access site.

Table 1. Export Catheter Flow Rate

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for the full product information.