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

Model Number	9-ATV08F45/80
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	11/07/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that on (b)(6) 2025, an 8f amplatzer trevisio delivery system was chosen for a procedure.During preparation, while an amplatzer septal occluder device was being loaded into the 8f amplatzer trevisio delivery system, a leak or spurting was observed from what was initially thought to be the connection of the tap.However, it was later noted that the occurrence was very proximal to the connection of the three-way tap.A small visible hole was identified, and as the system was flushed, saline was seen coming out from the side, just below the tap on the tubing.The physician decided to use the same delivery system and completed the procedure.The patient remained hemodynamically stable throughout the procedure.No clinically significant delay occurred, and no adverse effects to the patient were reported.
Additional Manufacturer Narrative
It was reported that during the device preparation a crack was observed on the extension tubing, which is part of the hemostasis valve.A more comprehensive assessment of the device could not be performed as the device was not returned for analysis.No imaging was provided by the field.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.Based on the information received, the cause of the reported incident could not be conclusively determined.The lot was thoroughly reviewed, and no specific issues were found.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 23708806
• Report Number: 2135147-2025-07105
• Device Sequence Number: 10720763
• Product Code: DQY
• UDI-Device Identifier: 05415067030924
• UDI-Public: (01)05415067030924(17)271231(10)10673674
• 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): 12/30/2025

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-ATV08F45/80
• Device Catalogue Number: 9-ATV08F45/80
• Device Lot Number: 10673674
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• 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: 52 YR
• Patient Sex: Male