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

Catalog Number	9-ATV07F45/80
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024 a 7f amplatzer trevisio intravascular delivery system (atv) was selected to implant a device.During preparation of the delivery system, there was leakage from the side of the tip tube part was observed when flashing the loader.Continuous drip border between the tube and the dial.The procedure was continued and completed.No health impact has been reported.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of leak during flushing was reported.The device was returned to abbott for investigation.The investigation found that leakage occurred in between the extension tube and stopcock during flushing.The screw end of the extension tube was microscopically examined, and the extension tube was noted to be fractured.No other anomalies were observed.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.This includes inspection for damage during the packaging of the device in the tray and upon receipt of the part from the supplier.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The cause of the reported leak appears to be related to a fracture of the extension tube.The cause of the fracture of the extension tube could not be conclusively determined.It is possible the fracture was related to overtightening connection.However, this could not be confirmed.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: 19983746
• Report Number: 2135147-2024-03960
• Device Sequence Number: 17229162
• Product Code: DQY
• UDI-Device Identifier: 05415067030900
• UDI-Public: 05415067030900
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/23/2024

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 9-ATV07F45/80
• Device Lot Number: 9244571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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