BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR CONSOLE

    MDR report key: 1021131 · Received March 27, 2008

    Report

    Report Number
    2134265-2008-00909
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #2134265-2008-00907. IT WAS REPORTED THAT DURING AN ATHERECTOMY PROCEDURE, THE ROTATIONAL SPEED JUMPED AND A VESSEL PERFORATION OCCURRED. THE 90% STENOSED AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE 10MM-20MM TORTUOUS DIAGONAL ARTERY. THE PLATFORM SPEED WAS SET AT 165,000 RPMS ON THE ROTABLATOR CONSOLE. IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE NITROGEN TANK AND IT WAS SET AT AN APPROPRIATE FLOW RATE. UPON THE INITIAL RUN WITH THE ROTABLATOR ROTOLINK PLUS 1.25MM BURR, A DROP IN SPEED TO 154,000 - 155,000 RPMS WAS NOTED AFTER WHICH "SEVERAL" RUNS WERE MADE WITH MINIMAL SPEED CHANGE. ON AN UNSPECIFIED RUN, THE ROTABLATOR BURR SPEED "JUMPED" TO 188,000 RPMS AND A VESSEL PERFORATION WAS NOTED IN THE MID DIAGONAL ARTERY. A QUANTUM MAVERICK BALLOON OF UNKNOWN SIZE WAS INFLATED TO AN UNK PRESSURE AT THE PERFORATION SITE FOR AN UNSPECIFIED AMOUNT OF TIME TO SUCCESSFULLY TREAT THE PERFORATION. THE PATIENT'S STATUS IS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR CONSOLE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM MCX BOSTON SCIENTIFIC NA RC105704

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other| R