BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIUMPH-1 "VITALPORT"

    MDR report key: 399371 · Received June 12, 2002

    Report

    Report Number
    MW1025305
    Event Type
    Injury
    Date Received
    June 12, 2002
    Date of Event
    May 20, 2002
    Report Date
    May 29, 2002
    Manufacturer
    HORIZON MEDICAL
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN OR FOR EXPLANTATION OF MALFUNCTIONING VENOUS ACCESS DEVICE FROM LEFT SCV. FOUND TO BE SHEARED OFF "UNDER CLAVICLE W/APPROXIMATELY 1 1/2" OF CATHETER STILL ATTACHED TO PORT. DISTAL PORTION MIGRATED TO RIGHT ATRIUM AND SUPERIOR VENA CAVA. REMOVED PERCUTANEOUSLY VIA RIGHT COMMON FEMORAL BY RADIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH-1 "VITALPORT" VENOUS ACCESS SYSTEM LJT HORIZON MEDICAL TRIUMPH-1 4-5290518

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention