BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUGAR XT STEERABLE GUIDEWIRE HYDRO-TRACK

    MDR report key: 4192833 · Received October 17, 2014

    Report

    Report Number
    MW5038711
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AT THE END OF THE PROCEDURE, WIRE FRAGMENT BROKE OFF WHILE REMOVING WIRES FROM THE LEFT MAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663298 COUGAR XT STEERABLE GUIDEWIRE HYDRO-TRACK COUGAR XT STEERABLE GUIDEWIRE HYDRO-TRACK DQX MEDTRONIC 2017-06-27

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention