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

Model Number	9-ITV09F45/80
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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 on 16 jul.2025, a 9f amplatzer torqvue delivery system (ds) was selected for implant.It was noticed that there was saline leaking out of the transmission and switching system.It was noted that there was a crack at one of the connections.The device never made contact with the patient.The ds was replaced to resolve the event.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is doing well.
Additional Manufacturer Narrative
It was reported that during procedure the ds was leaking was confirmed.The investigation found that a fracture was found on the screw part of the extension tube.Upon testing it further, which was identified as the likely cause of the leak.Image provided by the field appeared to show the extension tube.As event appears to be related to a potential product quality issue; therefore, exception issue (b)(4) has been initiated to further investigate this complaint.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.
Additional Manufacturer Narrative
It was reported and confirmed that the hub of the y-connector extension tube was cracked.Investigation revealed a fracture on the screw part of the extension tube, which, upon further testing, was identified as the likely cause of the leak.As the 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.A review of the device history record confirmed that all manufacturing and inspection operations were properly performed and that the product met all specifications prior to shipment.Additionally, the observed bent damage on the returned delivery system may have resulted from shipping or transportation-related stress, which is also consistent with excessive manipulation.However, this cannot be determined.
Event or Problem Description
N/a.

• 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: 22750110
• Report Number: 2135147-2025-04420
• Device Sequence Number: 15842392
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: (01)00811806010861(17)270930(10)10558209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 10/24/2025

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-ITV09F45/80
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 10558209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 10/03/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/27/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Weight: 53 KG