MAUDE Adverse Event Report: Abbott Medical Amplatzer Torqvue Delivery System; Catheter, Percutaneous

Model Number	9-ITV06F180/80
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, an 8-6mm amplatzer duct occluder was chosen for implant using a 6f amplatzer torqvue delivery system for patent ductus arteriosus (pda) closure.Prior to use, the delivery sheath was inspected for damage, kinks, or obstructions, and the device was flushed and prepared according to the instructions for use (ifu).During the procedure, a cobra-head configuration of the occluder was observed.The occluder and delivery system were flushed and immersed in saline solution three times.Following each flush, the occluder was recaptured into the delivery system and redeployed in an attempt to restore the device configuration.Despite these efforts, the device did not return to its original configuration.The deformed device was never released from the delivery cable while inside the patient.It was reported that there was no angulation or kink in the delivery system and no interaction with cardiac structures during deployment.On the final recapture attempt, the tip of the torqvue delivery system was damaged, rendering the delivery system unusable.As a result, both the amplatzer duct occluder and the 6f amplatzer torqvue delivery system were removed and replaced.An 8-6 mm amplatzer duct occluder (lot: 10716983) and a 6f amplatzer torqvue delivery system (lot: 11159205) were subsequently used to successfully complete the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in the procedure and no adverse patient effects were reported.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• 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 ; +1(651)756-5400
• MDR Report Key: 50693698
• Report Number: 2135147-2026-06075
• Device Sequence Number: 9684601
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Report Date (Section B): 09/09/2026

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-ITV06F180/80
• Device Catalogue Number: 9-ITV06F180/80
• Device Lot Number: 11047125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2025
• 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: 4 MO
• Patient Sex: Male
• Patient Weight: 6 LB