BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITREX¿

    MDR report key: 7658043 · Received July 3, 2018

    Report

    Report Number
    7658043
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    October 3, 2017
    Report Date
    June 29, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A LEFT LEG ANGIOGRAM. THE NITREX QUIDEWIRE BROKE OFF INSIDE THE PATIENT'S LEFT DISTAL LEG. EV3 INC., NITREX GUIDEWIRE, .018" X 80CM ANGLED, INTERMEDIATE, REF/CATALOG NUMBER N180802.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503021 NITREX¿ WIRE, GUIDE, CATHETER DQX MEDTRONIC, INC. N180802 10802483

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA