BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITREX GUIDEWIRE

    MDR report key: 533986 · Received June 30, 2004

    Report

    Report Number
    2183870-2004-00002
    Event Type
    Injury
    Date Received
    June 30, 2004
    Date of Event
    June 14, 2004
    Report Date
    June 28, 2004
    Manufacturer
    EV3 INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "THE WIRE STICKS AND BENDS AND THE FLOPPY TIP IS TOO SOFT. HATE THE WIRE. USED THE N180802 WIRE THREE TIMES (THREE DIFFERENT WIRES) TO ACCESS A DILATED BILIARY SYSTEM AND THE SAME THING HAPPENED. THE PT BECAME SEPTIC DUE TO CHANGING OUT THE WIRES AND THE PROCEDURE GOING TOO LONG." "THE PT IS REPORTED AS SUBSEQUENTLY FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITREX GUIDEWIRE GUIDEWIRE DQX EV3 INC. N180802 213025

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other