Medtronic has issued a medical device safety alert concerning its HawkOne Directional Atherectomy System 6 Fr [H1-M,H1-M-INT, H1-S,H1-S-INT].
The manufacturer has received reports of tip damage during use of the affected medical device, which has resulted in some instances of tip detachment and embolization. According to investigation and engineering testing on returned device, tip damage is predominantly caused by guidewire prolapse. This can cause the guidewire to buckle into a loop and develop a kink during retraction of the catheter. Tip detachment may cause arterial dissection, arterial perforation, arterial rupture, ischemia, and/or vascular complications that could require surgical repair.
The manufacturer advises users to adhere to existing IFU instructions, and warnings and precautions listed below to reduce the risk of guidewire prolapse:
- Carefully remove the catheter from the patient under fluoroscopic guidance.
- Caution: Do not torque the catheter shaft more than 360° in one direction. Torquing the catheter shaft more than 360° in one direction could result in tip fracture or other device failure. If the HawkOne catheter is not rotating easily, reposition the catheter or predilate the lesion.
- Warning: Always use direct fluoroscopic observation when manipulating the HawkOne Catheter in the peripheral vessels. If resistance is met during manipulation, determine the cause of the resistance before proceeding
- Warning: Never advance the distal tip of the HawkOne catheter near the floppy end of the guidewire. If the HawkOne catheter is advanced to this position, it can cause the guidewire to buckle into a loop when retracting the catheter. If buckling occurs, remove the catheter and guidewire together to prevent potential damage to vessel walls. If resistance is still felt, remove the sheath together with the guidewire and catheter.
- Warning: Avoid excessive movement of the HawkOne catheter within the vessel at all times. Excess movement could result in embolization or vessel damage. In addition, excessive catheter manipulation while the cutter window is open could result in the embolization of previously excised tissue fragments.
- Warning: Do not use HawkOne catheter in bends in excess of 90°. Using in bends in excess of 90° can result in device failure.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 Dec 2021