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

Model Number	9-ITV06F180/80
Medical Device Problem Codes	Retraction Problem (1536); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Complete Heart Block (2627)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report number : 2135147-2019-00255.On (b)(6) 2019, an amplatzer muscular vsd occluder was selected for implant.The device was deployed but didn't fit the ventricular septal defect.The device was attempted to be retracted, but the occluder didn't collapse and retract into the delivery sheath.The tip of the delivery sheath kept folding in on itself.Meanwhile, the patient went into complete heart block and became hypotensive.The occluder and delivery system were withdrawn from the patient without collapsing the occluder.The procedure was cancelled and the patient was sent to the pediatric intensive care unit for continued monitoring.The heart block resolved without treatment.
Additional Manufacturer Narrative
The reported event of an inverted sheath tip was confirmed.Gross morphological examination revealed the tip of the sheath was bent and deformed, consistent with the soft tip inverting.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event 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: 8897452
• Report Number: 2135147-2019-00256
• Device Sequence Number: 259631
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: 00811806010779
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 04/30/2022
• Device Model Number: 9-ITV06F180/80
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 7003532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR