BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIUMPH-VTX

    MDR report key: 1211283 · Received October 20, 2008

    Report

    Report Number
    1056436-2007-00006
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    February 6, 2007
    Report Date
    February 12, 2007
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT "LOCKING MECHANISM HAS SLIPPED DOWN" WAS CONFIRMED. THE CATHETER ANTI-KINK SLEEVE WAS OBSERVED, DETACHED FROM THE LOCKING MECHANISM, AND OBSERVE HALF-WAY DOWN THE CATHETER. THE CATHETER ANTI-KINK SLEEVE REVEALED MEMORY WHERE IT HAD BEEN ATTACHED TO THE LOCKING MECHANISM. THE TITANIUM LOCKING MECHANISM REVEALED CLAMP MARKS. THE CAUSE OF THIS DETACHMENT OF THE CATHETER ANTI-KINK SLEEVE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    LOCKING MECHANISM HAS SLIPPED DOWN, AND WAS ERODING THOUGH CLAVICLE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH-VTX TRIUMPH-1 PORT LJT ANGIODYNAMICS, INC. NA 34080

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention