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

Model Number	9-TVLPC4F90/080
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	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a 5-4mm amplatzer piccolo occluder was chosen for a patent ductus arteriosus (pda) closure procedure using a 4f amplatzer torqvue low profile catheter.The patient is 1-year-old patient with a pda measuring 1 mm at the pulmonary artery (pa) side, 8 mm in length, and an ampulla of 6.8 mm, device closure using a piccolo 5¿4 was attempted.However, the delivery catheter could not be advanced across the ductus.An attempt was made to advance the piccolo into the pa, but it did not exit into the pa, and the device was retrieved back into the delivery catheter.During retrieval, resistance was felt, and cine imaging revealed that the catheter tip had flipped upward.The delivery catheter was therefore exchanged for a new one.Although passage to the pa was still not achieved, the device was successfully deployed with the pa side positioned intraductally and the aortic side disc sealing the ductus, and the procedure was completed.The patient remained hemodynamically stable throughout the procedure and there was no delay in the procedure.The patient was reported discharged.

• 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: 25086515
• Report Number: 2135147-2026-02990
• Device Sequence Number: 10433548
• Product Code: DQY
• UDI-Device Identifier: 00811806012926
• UDI-Public: (01)00811806012926(17)280430(10)10852366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/16/2026

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-TVLPC4F90/080
• Device Catalogue Number: 9-TVLPC4F90/080
• Device Lot Number: 10852366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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: 11 MO
• Patient Sex: Female