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

Model Number	9-TVLP4F90/080
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 4f amplatzer torqvue lp delivery system was selected for use in a pda occlusion procedure.The delivery system was inspected prior to use.During procedure, hemostatic valve leakage occurred and saline was observed to be leaking.No parts of the delivery system were observed to be damaged.The delivery system was exchanged for a new 4f amplatzer torqvue lp delivery system, which was used to successfully complete the procedure.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that hemostatic valve leakage occurred and saline was observed to be leaking.The investigation at abbott found that the leak test was performed using returned components.No leakage was noted when device was flushed with solution.Device was submerged under solution and flushed with air.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER TORQVUE LP
• 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: 22503577
• Report Number: 2135147-2025-03855
• Device Sequence Number: 21158046
• Product Code: DQY
• UDI-Device Identifier: 00811806011578
• UDI-Public: (01)00811806011578(17)280131(10)10739240
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131063
• 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): 08/19/2025

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-TVLP4F90/080
• Device Catalogue Number: 9-TVLP4F90/080
• Device Lot Number: 10739240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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: 3 YR
• Patient Sex: Male
• Patient Weight: 20 KG