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

Model Number	9-ITV09F45/80
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 9f amplatzer torqvue was chosen for use in a procedure.During preparation, it was noted that the three-way valve of the delivery system had cracked and was leaking fluid.The device never entered the patient anatomy.A replacement was used to complete the procedure successfully.There were no patient consequences or clinically significant delay.
Additional Manufacturer Narrative
An event of leak and crack of the extension tube was confirmed.The investigation found that the fracture was found at the connection of the extension tube to the stopcock, which appears to be the cause of the leak.However, the cause of the fracture could not be conclusively determined.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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.

• 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: 21909920
• Report Number: 2135147-2025-02161
• Device Sequence Number: 8728590
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: (01)00811806010861(17)270630(10)10428315
• 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,Followup
• Report Date (Section B): 06/10/2025

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: 10428315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 55 KG