BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIUMPH-1

    MDR report key: 128497 · Received October 28, 1997

    Report

    Report Number
    128497
    Event Type
    Injury
    Date Received
    October 28, 1997
    Date of Event
    October 11, 1997
    Report Date
    October 28, 1997
    Manufacturer
    HORIZON MEDICAL PROD
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A TRIUMPH-1 VASCULAR ACCESS PORT WAS IMPLANTED IN THE RT CHEST ON 10/10/97. MEDICATIONS INFUSED WITHOUT DIFFICULTY UNTIL SWELLING AT THE SITE AND A WET DRESSING WERE REPORTED ON 10/11/1997. A CHEST AP-PA-X-RAY SHOWED CATHETER DISLODGEMENT TO THE RIGHT ATRIUM. A FLUORO GUIDED RETRIEVAL OF THE CATHETER FRAGMENT WAS SUCCESSFUL ON 10/11/1997. THE PATIENT WAS TAKEN TO SURGERY ON 10/14/1997 FOR INSERTION OF A NEW VASCULAR ACCESS PORT AND REMOVAL OF THE OLD PORT. ON CHECKING THE OLD PORT; THE SNAPPING MECHANISM REPORTEDLY WOULD NOT LOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH-1 Implant PORT LJT HORIZON MEDICAL PROD * 500133

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention