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); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 8f and 9f amplatzer trevisio delivery systems were selected for a procedure.During preparation, issues were observed sequentially with both systems.The extension tubing were spraying and leaking below the locks.Pecifically, the extension tubing on each system exhibited leakage in the form of a saline spray, with an estimated volume of approximately 20 ml.No visible damage was noted on the tubing or other components.A pre-use inspection of both delivery systems was performed, and no abnormalities were identified at that timethe procedure was completed using a 12 f amplatzer trevisio delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 8f and 9f amplatzer trevisio delivery systems were selected for a procedure.During procedure issues were observed sequentially with both systems.The extension tubing were spraying and leaking below the locks.Specifically, the extension tubing on each system exhibited leakage in the form of a saline spray, with an estimated volume of approximately 20 ml.Both delivery systems entered the patients anatomy.It was reported that they were considered as the issue.The extension tubing was reported to be the one with the issue.No visible damage was noted on the tubing or other components.A pre-use inspection of both delivery systems was performed, and no abnormalities were identified at that timethe procedure was completed using a 12 f amplatzer trevisio delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of fluid leak and fracture was reported.The device was returned to abbott for investigation and when analyzed, the extension tube was confirmed to be cracked.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.The event appears to be related to a potential product quality issue, exception issue (b)(4) has been initiated on 31 january 2025 to further investigate this complaint.The investigation determined that the cracking observed in the female luer component of the amplatzer delivery system was due to excessive manual assembly force applied during manufacturing.This force introduced residual stress into the plastic material, which over time and under elevated temperatures led to delayed cracking.

• 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: 23570967
• Report Number: 2135147-2025-06690
• Device Sequence Number: 18700325
• Product Code: DQY
• UDI-Device Identifier: 05415067030924
• UDI-Public: (01)05415067030924(17)280331(10)10795659
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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-ATV08F45/80
• Device Catalogue Number: 9-ATV08F45/80
• Device Lot Number: 10795659
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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 Age: 70 YR
• Patient Sex: Male