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

Model Number	9-ITV10F45/80
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Air Embolism (1697)
Type of Reportable Event	Serious Injury
Event or Problem Description
On an unknown date an amplatzer torqvue delivery system was selected for use.During the procedure, bubbles were visualized in the delivery sheath loader and the patient experienced st elevation with chest pain.No air was visualized in the patient.The device was replaced and the procedure was completed with no adverse patient consequences.The user tested the device ex vivo and replicated the issue.Following the procedure.The patient was asymptomatic.
Additional Manufacturer Narrative
The reported event of bubbles present in the loader could not be confirmed.The investigation confirmed the device met 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 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: 9075043
• Report Number: 2135147-2019-00289
• Device Sequence Number: 11382109
• Product Code: DQY
• UDI-Device Identifier: 00811806010878
• UDI-Public: 00811806010878
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: 10/31/2020
• Device Model Number: 9-ITV10F45/80
• Device Catalogue Number: 9-ITV10F45/80
• Device Lot Number: 6218273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/14/2019
• 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: Other
• Patient Age: 33 YR