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

Model Number	9-ATV08F45/80
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported on (b)(6) 2021, a amplatzer¿ trevisio¿ intravascular delivery system (ds) was used in procedure.The user reports that the 8 fr ds presented with damage, stating the sheaths distal end broke which did not allow the device to advance properly and reported the sheath¿s distal end was " deformed" at the moment of the femoral vascular access.A hematoma on the vascular access site was a reported complication.The hematoma resolved with local pressure and transitory femoral introducer however it is in the physicians opinion that the patient experienced adverse health consequences due to the performance of the product.
Additional Manufacturer Narrative
An event of difficulty to advance the device and deformed distal end of sheath were reported.Gross examination found that the sheath was kinked.The tip deformation was confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications, including visual inspection for any damage.The cause of the reported event could not be conclusively determined.

• Brand Name: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11795597
• Report Number: 2135147-2021-00160
• Device Sequence Number: 14463872
• Product Code: DQY
• UDI-Device Identifier: 05415067030924
• UDI-Public: 05415067030924
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 9-ATV08F45/80
• Device Catalogue Number: 9-ATV08F45/80
• Device Lot Number: 7677516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 05/09/2021
• Supplement Report FDA Received Date: 08/18/2021
• 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: 63 YR
• Patient Weight: 59