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

Model Number	9-ITV09F45/80
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 9f amplatzer torqvue delivery system was selected for use.During device preparation, the delivery system was inspected prior to use.During implant, while evacuating air from the occluder and delivery sheath, it was observed that the three-way valve of the delivery system was cracked and was leaking fluid.The location of the leak was at the extension pipe under the three-way valve.No other damagers were observed.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
It was reported that during procedure the delivery system was leaking was confirmed.The investigation found that a fracture was found on the screw part of the extension tube.Upon testing it is further, which was identified as the likely cause of the leak.Imaging provided by the field appeared to show the extension tube.As event appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications prior to shipment.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22097451
• Report Number: 2135147-2025-02821
• Device Sequence Number: 7424974
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: (01)00811806010861(17)270731(10)10455344
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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 Model Number: 9-ITV09F45/80
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 10455344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 67 KG