Indications, Safety, and Warnings
Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warning and precautions.
The Export™ 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.
- If the Export™ aspiration catheter is to be used with an 0.36 mm (0.014 in) guidewire, consult the guidewire instructions for use (IFU) prior to use.
- If the Export™ aspiration catheter is to be used with a minimum 6F guiding catheter (1.78 mm [0.070 in] minimum ID) or 7F guiding catheter (2.03 mm [0.080 in] minimum ID), consult the guide catheter IFU prior to use.
- For single patient use only. Do not reuse, reprocess or resterilize this product. Reuse, reprocessing or resterilization 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. Cleaning, disinfection and resterilization may compromise the essential material and design characteristics of the device leading to device failure.
- 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 Export™ aspiration catheter should be handled carefully. Prior to use inspect the Export™ aspiration catheter carefully for bends, kinks, or other damage. Do not use a damaged Export™ aspiration catheter.
- Do not attempt to advance or retract the Export™ aspiration 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™ aspiration catheter specifically in the region distal to the guide catheter and proximal to the Export™ aspiration catheter marker band. Should a loop or excessive slack in the wire be visualized, do not attempt to retract the Export™ aspiration catheter into the guide catheter until the loop or excessive slack is eliminated. Retracting the Export™ aspiration catheter without straightening the wire may potentially tear the wire lumen which could cause dislodgement of the marker band into the vasculature.
- Due to the presence of DEHP in the extension tubing of this device, it is not recommended for use in minors and pregnant or nursing women.
- After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
- The Export™ aspiration catheter and accessories should be used in conjunction with fluoroscopic guidance and proper anticoagulation agents.
- Store catheters in a cool, dry place.
- When using the Export™ aspiration catheter for fluid delivery, do not exceed the maximum flow rate specified for the device (see Table 1).
- This device is supplied sterile, and is designed and intended for single use only. DO NOT resterilize and/or reuse the device.
- 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. Instructions for Use English 3
As with most percutaneous interventions, potential adverse events include: death, myocardial infarction, coronary or bypass graft thrombosis or occlusion, myocardial ischemia, stroke/CVA, emergent or nonemergent bypass graft surgery, emboli (air, tissue or thrombotic), dissection, arterial perforation, arterial rupture, ventricular fibrillation, hemorrhage, hypotension,
Table 1. Export™ Aspiration Catheter Flow Rate