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

Model Number	9-ITV09F45/80
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of self-limiting transient ecg changes suspected to be caused by an air embolism was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2020, a 25mm amplatzer pfo was selected for implant.The device was mis-sized too small due to the patient's anatomy.The device was exchanged for a 30mm amplatzer pfo.After introducing the 30mm device, self-limiting transient ecg-changes occurred.It was suspected that an air-embolism caused the ecg-changes.After completing the pfo procedure, a diagnostic coronary intervention was performed to exclude an air embolism in the coronaries, in which it resulted in normal results.The ecg-change resolved without intervention.The patient remained hemodynamically stable.There was a delay in the procedure due to the event and the coronary intervention afterwards.

• 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: 9833205
• Report Number: 2135147-2020-00115
• Device Sequence Number: 2787075
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: 00811806010861
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/15/2020

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: 02/28/2022
• Device Model Number: 9-ITV09F45/80
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 6908187
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/15/2020
• 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