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	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6)2026, a 6mm x 4 mm amplatzer pda occluder was chosen for implant using a 6f amplatzer torqvue delivery system.The pda was measured at 2 mm.The patient did not have tortuous anatomy.The delivery sheath was inspected prior to use, and no damage, kinks, or obstructions were observed.The device was flushed and prepared according to the instructions for use (ifu) prior to delivery.During the first deployment attempt, it was noted that the retention disc of the pda device was successfully opened and positioned across the pda.However, the device position was deemed unsatisfactory.The physician attempted to recapture the device for repositioning but experienced difficulty retrieving the device into the sheath.Upon inspection, the tip of the sheath was found to be bent, which hindered device retrieval.Additional force was applied, and the device was successfully recaptured and withdrawn into the sheath.The 6f sheath was then exchanged for a new 7f amplatzer torqvue delivery system (lot no.11309053).The device was flushed, reloaded, and redeployed.The second deployment was successful, and the device was implanted in the desired position.The procedure was completed successfully without any patient injury or adverse clinical consequences.The patient remained stable throughout the procedure and upon completion of the intervention.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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: 50801584
• Report Number: 2135147-2026-06270
• Device Sequence Number: 8653455
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 09/17/2026

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: 11020686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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 Sex: Unknown