BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTOLINK

    MDR report key: 4114501 · Received September 17, 2014

    Report

    Report Number
    MW5038285
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ROTOBURR SHEARED OFF THE ROTOFLOPPY WIRE DURING PLATFORM/BREAKCHECK, PART OF ROTATIONAL ATHERECTOMY PROCEDURE. THE ROTOFLOPPY WIRE WAS SHEARED APPROXIMATELY 1" FROM THE GUIDE CATHETER, LEAVING US NO WAY TO MOVE ANY EQUIPMENT IN OR OUT OF THE GUIDER TO TREAT THE LESION. PT WAS ON A CRITICAL TIMELINE FOR TREATMENT OF LESION IN RIGHT CORONARY ARTERY AS HE WAS IN CARDIOGENIC SHOCK FROM HIS ACUTE MI. WE BUDDY WIRED BACK DOWN THE VESSEL WITH A NEW WIRE AND BALLOON COMBINATION, WHILE PINNING THE SHORT ROTOFLOPPY WIRE TO A TOWEL ON THE FIELD. AFTER SUCCESSFUL REWIRING, THE ROTOFLOPPY WIRE WAS REMOVED SAFELY AND NO HARM TO THE PT RESULTED FROM THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575578 ROTOLINK BURR MCX BOSTON SCIENTIFIC ROTOLINK PLUS 1.75 16922032

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening