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

Model Number	9-ITV08F45/80
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, an 8f amplatzer torqvue 45/80 was utilized during a procedure.When advancing through the anatomy there was advancement difficulty and the blue tip became damaged.A replacement 9f amplatzer torqvue was attempted to be used as a replacement but also met resistance while advancing which damaged the blue tip.A non-abbott replacement device was used to complete the procedure.There were no patient consequences or clinically significant delay.
Additional Manufacturer Narrative
An event of difficult to advance through patient anatomy and material deformation (blue tip damaged) was reported.The reported difficult to advance through patient anatomy could not be replicated in a testing environment.The reported material deformation of the blue tip was confirmed.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 incidents reported from this lot.All available information was investigated and based on available information, a cause for the reported difficult to advance through patient anatomy and material deformation (blue tip damaged) could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 21723477
• Report Number: 2135147-2025-01643
• Device Sequence Number: 21186946
• Product Code: DQY
• UDI-Device Identifier: 00811806010847
• UDI-Public: (01)00811806010847(17)270331(10)10293321
• 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): 04/17/2025

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-ITV08F45/80
• Device Catalogue Number: 9-ITV08F45/80
• Device Lot Number: 10293321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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 Sex: Unknown