Reportable based on device analysis completed on 23sep2021.It was reported that shaft kink occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilation.During the procedure, it was noted that the shaft was kinked.The procedure was completed with another of same device.There were no patient complications nor injuries reported.However, returned device analysis revealed a separation of the hypotube.
|