MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	9-ITV06F180/80
Medical Device Problem Codes	Mechanical Problem (1384); Retraction Problem (1536)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
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 Manufacturer Narrative
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.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9772694
• Report Number: 2135147-2020-00085
• Device Sequence Number: 10956945
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: 00811806010779
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 9-ITV06F180/80
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 6271477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/28/2020
• Initial Report FDA Received Date: 03/01/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 9-VSD-MUSC-010.
• Outcome Attributed to Adverse Event: Other; Required Intervention