Related manufacturer reference number 2135147-2020-00086.On (b)(6) 2020, an 8mm amplatzer muscular vsd was attempted to be implanted.It was mis-sized too small and exchanged for a 10mm amplatzer muscular vsd occluder (lot # 6925807) with a 6f amplatzer torqvue delivery system.When positioning the device, it was determined to be mi-sized too small.When attempting to retract the device, the device would not re-sheath nor retract into the 6f delivery sheath and a vascular issue occurred with hematoma at the groin.The device and the delivery system was removed and the delivery system was exchanged for an 8f torqvue 45/80 delivery system (lot # unknown) and a new 10mm muscular vsp (lot # 6942246).The physician noted that the patient had a torturous anatomy and there was no kinks noted on the first delivery system (lot # 6271477).There was a clinically significant delay in the procedure.The patient is stable during and post procedure.
|
Additional information for : d10, g4, g7, h2, h3, h6, and h10.An event of difficulty retracting the occluder into the sheath was reported.The investigation found that the soft tip of the sheath was damaged and inverted, which is consistent with difficulties retracting the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.
|