Reportable based on device analysis completed on (b)(3) 2023.It was reported that the catheter got separated near the hub.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, after rota, the device was delivered but it got kinked and separated near the hub outside the patient's body.The procedure was completed with a different device.No complications reported and there was no patient injury.However, device analysis revealed a hypotube break located 116cm proximal from the tip end of the device.
|