BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR GUIDE WIRE

    MDR report key: 1030708 · Received April 15, 2008

    Report

    Report Number
    2134265-2008-01088
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT# 2134265-2008-01089. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE WIRE AND BURR BECAME STUCK. THE 99% STENOSED, CALCIFIED LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY. THE EXTRA SUPPORT ROTAWIRE WAS ADVANCED TO THE LESION, HOWEVER, IT COULD NOT BE ADVANCED DISTAL TO THE LESION. IN ORDER TO ABLATE THE LESION, THE BURR WAS ROTATED AT THE PROXIMAL PORTION OF THE DISTAL TIP OF THE EXTRA SUPPORT ROTAWIRE. TWO ABLATIONS WERE COMPLETED AT 190,000 RPMS. THE EXTRA SUPPORT ROTAWIRE THEN BECAME STUCK IN THE BURR AND WAS NOT ABLE TO BE REMOVED. BOTH DEVICES WERE REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED WITH THESE DEVICES. NO PT COMPLICATIONS WERE REPORTED, AND PT STATUS WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC EX SUP RTW 11323002

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: ZEON| GUIDEWIRE| GUIDECATHETER: LAUNCHER| RUNTHROUGH