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	Thrombus (2101)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 18mm amplatzer septal occluder(aso) was selected for implant in the patient after measuring the size with a sizing balloon.During the procedure the aso was attempted to be implanted, but the physician decided that the aso was under-sized.Thrombus had formed in the patient and adhered to the delivery cable during the procedure.The physician was concerned about the thrombus adhering on the delivery cable and decided to remove the 18mm aso and the 9f 45/80 amplatzer torqvue delivery system from the patient.The devices were replaced with a 20mm amplatzer septal occluder(aso) and a 10f 45/80 amplatzer torqvue delivery system to continue the procedure.The 20mm aso was successfully implanted with no adverse consequences to the patient.It took time in the attempt to deploy the first 18mm aso in the patient's defect, so the delivery cable and the sheath were in the patient longer than usual procedures.However, the delay was not significant and the patient remained hemodynamically stable during the procedure.
Additional Manufacturer Narrative
An event of thrombus in the delivery cable was reported.The investigation found that residue consistent with blood was present on the delivery cable 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.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: 10359962
• Report Number: 2135147-2020-00340
• Device Sequence Number: 11413895
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: 00811806010861
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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: 08/31/2022
• Device Model Number: 9-ITV09F45/80
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 7204927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 09/13/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 09/15/2020
• 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
• Patient Age: 4 YR