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

Model Number	9-ITV07F180/80
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2025, a 6f amplatzer torqvue delivery system was selected for use.During device preparation, when they were flushing the system, leaking saline was observed in a continuous drip on the extension tube next to the stopcock.The device never made contact with the patient and was exchanged for a new 7f amplatzer torqvue delivery system.However, leaking saline issue also occurred after patient contact - leak was observed during flushing at the hemostasis valve.The device was replaced with a third new unknown sized unknown manufacturer device to complete the procedure.The patient was reported to be in stable condition.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of fracture on the y-connector extension tube was reported.The device was returned to abbott for analysis, it was found that the delivery system components were all each visually examined and the hemostasis valve was found to have a fracture damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Based on the available information, 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.

• 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: 23824960
• Report Number: 2135147-2025-07448
• Device Sequence Number: 5067593
• Product Code: DQY
• UDI-Device Identifier: 00811806010793
• UDI-Public: (01)00811806010793(17)280331(10)10821522
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/03/2026

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-ITV07F180/80
• Device Catalogue Number: 9-ITV07F180/80
• Device Lot Number: 10821522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 02/15/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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 Sex: Female