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

Model Number	9-ATV10F45/80
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
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 report number: 2135147-2021-00017.On (b)(6) 2020, a 24 mm amplatzer septal occluder was selected for implant.During device placement, while the left disc was deployed, the physician wanted to change the orientation of the device.While the physician attempted to recapture the device, it was realized that the occluder had became disconnected from the amplatzer trevisio intravascular delivery system delivery cable.The delivery cable was able to screwed back onto the occluder and was subsequently recaptured and removed.A new amplatzer torqvue delivery system delivery system was then used to successfully implant a new 24 mm amplatzer septal occluder.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is stable.
Additional Manufacturer Narrative
An event of the occluder prematurely detaching from the cable was reported.A more comprehensive assessment could not be performed as 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.

• Brand Name: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11165623
• Report Number: 2135147-2021-00018
• Device Sequence Number: 19813467
• Product Code: DQY
• UDI-Device Identifier: 05415067030948
• UDI-Public: 05415067030948
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K190581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 9-ATV10F45/80
• Device Catalogue Number: 9-ATV10F45/80
• Device Lot Number: 7411833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1