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SmartClaw™ Thrombectomy Catheter Brief Summary

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Indications, Safety and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATION FOR USE

The SmartClaw Thrombectomy Catheter is indicated for the non-surgical removal of thrombi and emboli from the peripheral vasculature. 

CONTRAINDICATIONS

None.

WARNINGS

  • The SmartClaw Thrombectomy Catheter should not be used in any patient that is not clinically appropriate or anatomically suitable for such a procedure to be performed.
  • The SmartClaw Thrombectomy Catheter is not intended for use in coronary arteries, pulmonary vasculature, or neurovasculature.
  • The SmartClaw Thrombectomy Catheter has not been tested for the removal of atherosclerotic plaque.
  • The SmartClaw Thrombectomy Catheter should be used in conjunction with fluoroscopic guidance and proper anticoagulation agents
  • Do not use the SmartClaw Thrombectomy Catheter if it is kinked or damaged.
  • Do not use product(s) past the expiration date specified on the label.
  • The SmartClaw Thrombectomy Catheter is for single use only. Do not reuse, reprocess or re-sterilize as any of these may compromise the integrity of the device(s) resulting in device failure and potential patient injury.
  • The SmartClaw Thrombectomy Catheter is not intended for use with power injectors.
  • Pulling the SmartClaw Thrombectomy Catheter with excessive force may result in injury to the vessel or may result in damage to the device including detachment of part of the device in the vessel.
  • The SmartClaw Thrombectomy Catheter should not be used in patients with known allergies to nickel or to the materials found in the Technical Specifications section. Where material sensitivity is suspected, appropriate tests should be performed and sensitivity ruled out prior to use.

PRECAUTIONS

  • The SmartClaw Thrombectomy Catheter should only be used by physicians experienced in interventional endovascular procedures requiring fluoroscopic visualization.
  • Do not use if package is open or damaged.
  • Flush the SmartClaw Thrombectomy Catheter with sterile saline prior to use.
  • Do not continue to pull the SmartClaw Thrombectomy Catheter if excessive resistance is experienced. Instead, stop and assess the cause of resistance using fluoroscopy.
  • Do not use if product damage is detected. If any portion of the SmartClaw Thrombectomy Catheter is damaged, dispose and open a new package.
  • Collapse basket when advancing or retracting through the free end of a stent to avoid potential entanglement or stent damage.
  • Depress button when advancing slider and collapsing basket to prevent damage to device.

ADVERSE EVENTS- POTENTIAL RISKS

The following are known adverse effects and potential risks with the use of this type of device:

  • Access site complications (hematoma, hemorrhage, vessel trauma, or other)
  • Allergic reaction (contrast, device, or other)
  • Death
  • Device malfunction
  • Embolism (air, plaque, thrombus, device, tissue, or other)
  • Hemorrhage
  • Infection/sepsis
  • Ischemia
  • Need for additional intervention or surgery
  • Thrombus / thrombosis
  • Vasospasm
  • Vessel trauma (arteriovenous fistula, dissection, perforation, pseudoaneurysm, rupture, or other injury)
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