Indication for Use
The Aspirex™ Thrombectomy System is indicated for the removal of acute emboli and thrombi from vessels of the peripheral venous system.
The 6F and 8F Aspirex™ Thrombectomy Catheters are indicated for the removal of acute emboli and thrombi from hemodialysis access grafts and native arteriovenous fistulas.
Contraindications
Not for use in the vessels of the cardiac, pulmonary, coronary and neurovasculature.
Warnings
The Aspirex™ Thrombectomy Catheters may only be used in conjunction with the Drive System and the provided Aspirex™ Guidewire of appropriate size. The Aspirex™ Thrombectomy Catheters are supplied sterile and are intended for single use only. Do not resterilize or reuse the device. Failure to ensure sufficient blood flow to the catheter head could result in drawing of the vessel wall into a side window(s). Failure to ensure sufficient blood flow through the catheter head could result in damage to the catheter due to overheating. Do not operate the Aspirex™ Thrombectomy Catheter near fractured areas of broken stents or stent grafts. Do not use the Aspirex™ Thrombectomy Catheter or Aspirex™ Guidewire if kinked or through a kinked or damaged introducer sheath. Do not use in sharply angled vessels with a <2 cm radius. Do not use in immature native AV fistula or recently-implanted AV graft. Caution should be used when dislodging the platelet plug at the arterial anastomosis to minimize the risk of arterial embolization. It is recommended to select the largest catheter diameter in order to reduce the potential for embolism. The catheter size should be selected based on the minimum vessel diameter. The risk of embolism increases with the difference in diameter between the native vessel and the minimum vessel diameter.
Precautions
The Aspirex™ Thrombectomy System should only be used under adequate visual monitoring with suitable radiographic techniques. The Aspirex™ Thrombectomy System does not contain any parts that can be maintained or serviced by the end-user. Do not repair or change the configuration of the product. The Aspirex™ Thrombectomy Catheters must not operate dry and must be primed and flushed using heparinized saline before and during use per the Directions for Use. The Aspirex™ Thrombectomy Catheters must not operate without an Aspirex™ Guidewire. Do not use the Aspirex™ Thrombectomy Catheter Set when product damage is evident, if packaging is damaged, or if the sterilization expiration date has passed. Ensure the Aspirex™ Thrombectomy Catheter is manipulated slowly with a back-and-forth motion as described in the Directions for Use. Insufficient blood flow through the catheter may result in intra-catheter clot formation, slow or absent therapeutic function, fracture of the helix and/or guidewire, and/or overheating of the catheter. The device is intended for use by physicians who have received appropriate training.
Potential Adverse Events
Potential adverse events include, but are not limited to: Acute occlusion; Air embolism; Allergic/anaphylactic reactions; Amputation; Arteriovenous fistula, pseudo-aneurysm; Atrial Fibrillation; Death; Detachment of catheter or guidewire; Device malfunction; Distal embolization; Emboli; Emergent surgery; Entrapment; Excessive blood loss; Hematoma, hemorrhage; Hypotension; Inability to completely remove thrombus; Intimal disruption; Ischemia; Kidney damage from contrast media; Myocardial infarction; Pseudoaneurysm; Respiratory failure; Sepsis/Infection; Thrombophlebitis; Thromboembolic events; Vessel spasm, thrombosis, dissection or perforation, or valve damage.
