BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-VU CATHETER

    MDR report key: 911071 · Received March 20, 2007

    Report

    Report Number
    1319211-2007-00008
    Event Type
    Malfunction
    Date Received
    March 20, 2007
    Date of Event
    February 20, 2007
    Report Date
    March 20, 2007
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I PROVIDED 2 SOS (0) CATHETER. DR. SAID THE 1ST SOS (O) TIP DISLODGED. YOU WILL NOTICE THAT A PART OF THE BLACK TIP COMPLETELY DISLODGED. THE 2ND SOS (O) HE USED: AS HE REINSERTED THE WIRE, THE WIRE WENT THROUGH THE TIP. YOU WILL NOTICE THIS ON THE ON THAT THE TIP IS BARELY ATTACHED. THE DR IS CONCERNED IF IT IS A TECHNIQUE ISSUE OR CATHETER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT-VU CATHETER ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS, INC. * 573010

    Patients

    Seq Age Sex Outcome Treatment
    1 *