BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUGAR XT HYDRO TRACT GUIDE WIRE

    MDR report key: 2830173 · Received November 6, 2012

    Report

    Report Number
    MW5027569
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMERGENT CORONARY INTERVENTION: COUGAR XT GUIDE WIRE WAS SUCCESSFULLY ADVANCED - ATTEMPT MADE TO ADVANCE A PRONTO V3 THROMBECTOMY CATHETER RESULTED IN PROLAPSE OF GUIDE WIRE IN THE CATHETER. COUGAR XT ADVANCED INTO PDA, THE THROMBUS EXTRACTION CATHETER, PRONTO 3, WAS ADVANCED, ATTEMPT WAS MADE TO WITHDRAW BLOOD WITH SUCTION, W/O BLOOD RETURN. A SECOND ATTEMPT, THE CATHETER COULD NOT BE MOVED SEPARATELY OVER THE WIRE, AND THE GUIDE WIRE AND PRONTO V3 WAS REMOVED. UPON VISUAL INSPECTION, THE GUIDE WIRE ALONG THE THROMBUS EXTRACTION CATHETER HAD SOME DEFECTS, WITH THE GUIDE WIRE TRANSACTED. THE GUIDE WIRE WAS REMOVE IN IT'S ENTIRETY, 2 ADD'L PRONTO V3 CATHETERS USED IN PROCEDURE-1 WITH KINKING, REQUIRING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUGAR XT HYDRO TRACT GUIDE WIRE COUGAR GUIDE WIRE DQX MEDTRONIC, INC. #GM591
    2 PRONTO V3 EXTRACTION CATHETER EXTRACTION CATHETER DXE VASCULAR SOLUTIONS 559496

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention