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

Model Number	9-ITV06F180/80
Medical Device Problem Codes	Fracture (1260); Device Difficult to Setup or Prepare (1487); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025, a 10-8mm amplatzer duct occluder was selected for implant using a 6f amplatzer torqvue delivery system.All steps were performed per instructions for use (ifu).During the procedure it was noted that the occluder could not be retracted into the delivery system.The hemostasis valve also appeared to be cracked.The delivery system was removed from the patient and replaced with a new 7f amplatzer torqvue delivery system.There were no adverse effects to the patient.The patient status was stable.
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.
Additional Manufacturer Narrative
An event of a device difficult to setup or prepare and fracture on the y-connector extension tube was reported.A returned device assessment could not be performed as the device was not returned for analysis.The imaging suggests that the fracture is located at the connection between the hemostasis valve and the extension tube.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no similar complaints associated with any other devices from the lot.Based on the available information, the cause for the device difficult to setup or prepare could not be determined.The event of the fracture on the y-connector extension tube 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 investigation determined that the cracking observed in the female luer component of the amplatzer delivery system was due to excessive manual assembly force applied during manufacturing.This force introduced residual stress into the plastic material, which over time and under elevated temperatures led to delayed cracking.
Event or Problem Description
It was reported on (b)(6) 2025 a 10-8mm amplatzer duct occluder was selected for implant using a 6f amplatzer torqvue delivery system.All steps were performed per instructions for use (ifu).During the procedure it was noted that the occluder could not be retracted into the delivery system.The hemostasis valve also appeared to be cracked.The delivery system was removed from the patient and replaced with a new 7f amplatzer torqvue delivery system.There were no adverse effects to the patient.The patient status was stable.

• 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 ; 6517565400
• MDR Report Key: 23865782
• Report Number: 2135147-2025-07585
• Device Sequence Number: 11874840
• Product Code: DQY
• UDI-Device Identifier: 00811806010779
• UDI-Public: (01)00811806010779(17)270930(10)10553097
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 01/14/2026

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: 10553097
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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
• Patient Sex: Unknown