MAUDE Adverse Event Report: Abbott Medical Amplatzer Trevisio Intravascular Delivery System; Catheter, Percutaneous

Model Number	9-ATV09F45/80
Medical Device Problem Code	Fluid/Blood Leak (1250)
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 9f amplatzer trevisio intravascular delivery system was chosen for a procedure.During the device preparation, while flushing the device, it was noted that a leak was observed at the y-connector thread.The flushing of the device was performed according to the instructions for use (ifu).The delivery system had been inspected prior to use, and no cracks or other abnormalities were observed.No damage to the product packaging was noted before opening, and no cracks or damage were observed on the delivery system.The device had not been handled or manipulated prior to the observation of the leakage.The reported leakage was less than 200 ml and did not result in any blood loss.Despite the leakage, the procedure was completed successfully using the same device.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.
Additional Manufacturer Narrative
An event of a fluid leak was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the available information, a cause for the reported fluid leak could not be determined.There is no indication of a product issue with respect 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 ; +1(651)756-5400
• MDR Report Key: 50505779
• Report Number: 2135147-2026-05896
• Device Sequence Number: 15810554
• Product Code: DQY
• UDI-Device Identifier: 05415067030931
• UDI-Public: (01)05415067030931(17)280229(10)10741580
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/24/2026

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-ATV09F45/80
• Device Catalogue Number: 9-ATV09F45/80
• Device Lot Number: 10741580
• 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: 08/03/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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: Unknown