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

Model Number	9-ATV07F45/80
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
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 (b)(6) 2025, a 7f amplatzer trevisio delivery system was selected for use.During use, after insertion into the patient, as the occluder was being loaded, it was noted that there was a leak coming from what was initially thought as the connection of the tap and the 3-way tap was exchanged.However, it was then noted that "very proximal to the connection of the 3 way tap" was a small visible hole that was leaking saline out the side "just below the tap." the user was offered to exchange the device, however the physician elected to proceed and the device was successfully implanted.The patient was reported to have been discharged home.
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, exception issue 133969 has been initiated to further investigate this complaint.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 damages on the loader may have resulted from damage during use and/or shipping or transportation-related stress in the return to abbott.However, this cannot be determined.

• Brand Name: AMPLATZER TREVISIO INTRAVASCULAR 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: 23410630
• Report Number: 2135147-2025-06188
• Device Sequence Number: 10408147
• Product Code: DQY
• UDI-Device Identifier: 05415067030900
• UDI-Public: (01)05415067030900(17)280131(10)10723897
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190581
• 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): 12/12/2025

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-ATV07F45/80
• Device Catalogue Number: 9-ATV07F45/80
• Device Lot Number: 10723897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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: 70 YR
• Patient Sex: Female