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

Model Number	9-TVLP4F90/060
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
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 a 3mm x 4mm amplatzer piccolo occluder was selected for a procedure on (b)(6) 2025 using a 4f amplatzer torqvue low profile catheter to close a patent ductus arteriosus (pda) for a 2-week-old patient that weighed 1kg.The device was prepared per ifu.During the procedure, while advancing the occluder through the delivery catheter it was noted that there was a leak at the proximal end of the delivery catheter where the white tubing attaches to the blue catheter.The occluder was successfully implanted using the same delivery catheter.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
It was reported that during the device preparation it had a leak at the proximal end of the catheter was reported.A torqvue subassembly was returned and sent to the s&t (science and technology) testing for analysis.The tests indicated a severe crimp was observed in the tubing that is inline with the seam in the overmolded hub from the injection molding process.Detailed view of the faces of these crimped locations reveals that there is a full breach of the polymer tubing, which is likely the cause of leakage from the device during operation.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 21346230
• Report Number: 2135147-2025-00655
• Device Sequence Number: 13012620
• Product Code: DQY
• UDI-Device Identifier: 00811806011561
• UDI-Public: (01)00811806011561(17)270430(10)10353324
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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-TVLP4F90/060
• Device Catalogue Number: 9-TVLP4F90/060
• Device Lot Number: 10353324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN OCCLUDER
• Patient Age: 14 DA
• Patient Sex: Unknown
• Patient Weight: 1 KG