BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2072116 · Received April 28, 2011

    Report

    Report Number
    2134265-2011-01812
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE INITIAL INSPECTION OF THE CONSOLE FOUND THE VOID SEAL WAS BROKEN, A CUSTOMER LABEL AND TAPE WERE ON THE COVER, THE DISPLAY RPM IS BENT, THE FRONT PANEL LABEL IS PARTIALLY DELAMINATED, SCRATCHES ALL OVER THE CONSOLE, AND THE SERIAL NUMBER HAS BEEN OVERWRITTEN WITH "8490"-ACTUAL (B)(4). THE CONSOLE WAS UNABLE TO BE POWERED UP TO PERFORM ANY FUNCTIONAL TESTING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREP FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, NO RPM DISPLAY WAS NOTED. WHILE PLATFORM TESTING OF THE 1.5MM ROTALINK PLUS UNIT, THE UNIT HAD BURR ROTATION, AND ALL THE SOUNDS ASSOCIATED WITH A ROTATING BURR, BUT THERE WAS NO RPM READOUT ON THE ROTABLATOR CONSOLE. THE FIBER OPTICS CABLE WAS DISCONNECTED AND RECONNECTED AND NO RPM READOUT EVER APPEARED ON THE DISPLAY. A SECOND 1.5MM ROTALINK PLUS UNIT WAS OPENED WITH THE SAME NO RPM READOUT ISSUES. AGAIN TROUBLESHOOTING WAS PERFORMED WITH NO RESOLUTION. MEANWHILE, A ROTABLATOR CONSOLE WAS MADE AVAILABLE FROM ANOTHER FACILITY NEXT DOOR. ONCE THE SECOND ROTALINK PLUS UNIT WAS RECONNECTED TO THIS CONSOLE, THE PROCEDURE WAS ABLE TO BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS FINE. THE INITIAL 1.5MM ROTALINK PLUS WAS CHECKED POST-PROCEDURE AND THIS ALSO WORKED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREP FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, NO RPM DISPLAY WAS NOTED. WHILE PLATFORM TESTING OF THE 1.5MM ROTALINK PLUS UNIT, THE UNIT HAD BURR ROTATION, AND ALL THE SOUNDS ASSOCIATED WITH A ROTATING BURR, BUT THERE WAS NO RPM READOUT ON THE ROTABLATOR CONSOLE. THE FIBER OPTICS CABLE WAS DISCONNECTED AND RECONNECTED AND NO RPM READOUT EVER APPEARED ON THE DISPLAY. A SECOND 1.5MM ROTALINK PLUS UNIT WAS OPENED WITH THE SAME NO RPM READOUT ISSUES. AGAIN TROUBLESHOOTING WAS PERFORMED WITH NO RESOLUTION. MEANWHILE, A ROTABLATOR CONSOLE WAS MADE AVAILABLE FROM ANOTHER FACILITY NEXT DOOR. ONCE THE SECOND ROTALINK PLUS UNIT WAS RECONNECTED TO THIS CONSOLE, THE PROCEDURE WAS ABLE TO BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS FINE. THE INITIAL 1.5MM ROTALINK PLUS WAS CHECKED POST-PROCEDURE AND THIS ALSO WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT 22020-039-L

    Patients

    Seq Age Sex Outcome Treatment
    1 1.5MM ROTALINK PLUS UNITS X2.