Export® XT Aspiration Catheter
Indications and Intended Use
The Export 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 & Aspiration System consult the GuardWire Temporary Occlusion & Aspiration System IFU prior to use.
- 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 re-sterilize and/or reuse it.
- 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.
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 |
| Maximum Recommended Export Catheter Flow Rate |
| 60% Ionic Contrast Media |
1.8 ml/sec |
| 76% Ionic Contrast Media |
0.5 ml/sec |
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Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. See package insert for full product information.
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