BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR GUIDE WIRE

    MDR report key: 1051075 · Received May 22, 2008

    Report

    Report Number
    2134265-2008-01489
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME EVENT AS MFR REPORT #: 2134265-2008-01488. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, THE BURR AND GUIDE WIRE BECAME ENTRAPPED AND THE PT WENT TO BYPASS. THE TERRIBLY CALCIFIED LESION WAS LOCATED IN THE SOMEWHAT TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). TWO LESIONS WERE TREATED; FIRST THE 90% STENOSED MID LAD AND THEN THE 80% STENOSED DISTAL LAD. A ROTAWIRE WAS ADVANCED. THE ROTABLATOR SYSTEM WAS PLATFORMED AT 160,000 RPMS. THREE ABLATION RUNS WERE PERFORMED WITH THE ROTALINK PLUS 1.25MM BURR: 22 SECONDS, 31 SECONDS AND 23 SECONDS. DURING THE THIRD ABLATION RUN THE RPMS WENT DOWN TO 130,000. THE BURR AND THE ROTAWIRE BECAME ENTRAPPED IN THE MID LAD LESION DURING AN ATTEMPT TO WITHDRAW IT. AN INTRA-AORTIC BALLOON PUMP WAS PLACED AND THE PT WAS TAKEN TO THE OPERATING ROOM WHERE A TRIPLE-VESSEL BYPASS WAS COMPLETED WITH SUCCESSFUL REMOVAL OF THE BURR AND A PORTION OF THE ROTAWIRE. THE CHEST WAS CLOSED. UNDER FLUOROSCOPY, THE CARDIOLOGIST THEN ATTEMPTED TO REMOVE THE REMAINDER OF THE BURR CATHETER SHAFT AND THE ROTAWIRE, THROUGH THE FEMORAL ARTERY, BUT WAS UNABLE TO DUE AN "UNCOILING" OF THE CATHETER SHAFT AND BOTH DEVICES BEING CAUGHT IN PLAQUE. THE CHEST WAS THEN REOPENED TO EXPLORE THE AORTIC ARTERY, AND THE CATHETER SHAFT AND ROTAWIRE WERE REMOVED WITH FORCEPS AND SOME FORCE. THE CHEST WAS THEN RE-CLOSED. THE PT TOLERATED THE PROCEDURE AND LEFT THE OPERATING ROOM IN HEMODYNAMICALLY STABLE CONDITION, AND WAS REPORTED TO BE IN AN 'OKAY' STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC FLOPPY ROTAWIRE 11061109

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R GUIDANT BMW UNIVERSAL GUIDEWIRE| MACH1 GUIDE CATHETER