Related manufacturer reference number 2135147-2020-00087.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.
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Additional information: d10, g4, g7, h2, h3, h6, and h10.An event of inability to retract the occluder into the sheath could not be confirmed.The investigation confirmed the occluder met dimensional and functional specifications when analyzed at abbott.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 event could not be conclusively determined.
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