BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITREX NITINOL GUIDEWIRE

    MDR report key: 8699461 · Received June 14, 2019

    Report

    Report Number
    8699461
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    January 30, 2019
    Report Date
    April 9, 2019
    Manufacturer
    EV3, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS LAST ATTEMPT TO OPEN ARTERY, GUIDEWIRE EMPLOYED - HOWEVER, BROKE OFF AT JUNCTURE BETWEEN FIRST AND SECOND DISTAL ENDS OF GUIDEWIRE. STAFF AND MD NOTE THE JUNCTURE IS NOT SMOOTH WHERE THEY MEET, AND SO MAY HAVE "CAUGHT" AND SHEERED OFF WHEN RETRACTED AT END OF CASE. PATIENT NEEDED AMPUTATION, BUT THIS WAS ANTICIPATED IN EVENT THIS LAST ATTEMPT WAS UNSUCCESSFUL. SO NO REAL HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494412 NITREX NITINOL GUIDEWIRE WIRE, GUIDE, CATHETER DQX EV3, INC. N143001

    Patients

    Seq Age Sex Outcome Treatment
    1 31390 DA