BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2100507 · Received May 24, 2011

    Report

    Report Number
    2134265-2011-02021
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE CONSOLE WAS RECEIVED IN GOOD CONDITION WITH A CUSTOMER LABEL ON THE COVER. DURING FUNCTIONAL TESTING WITH A 1.75MM BURR, THE FOLLOWING ISSUES WERE FOUND. THE MAXIMUM TURBINE PRESSURE IS SET SLIGHTLY LOW AT 81 PSI WHICH GENERALLY DOES NOT AFFECT CONSOLE FUNCTIONALITY. THE SETTING CAN BE INTERNALLY ADJUSTED TO BRING THE VALUE BACK INTO SPECIFICATION. ALSO, THERE IS A MASSIVE GAS/AIR LEAK AT THE TURBINE PRESSURE SWITCH. THE BURR SOUNDS LIKE IT IS ROTATING AT (NORMAL) HIGH SPEED, BUT THE ROTATIONAL SPEED IS NOT DISPLAYED (MEANING THAT THE LEAK DOES NOT APPEAR TO BE THE ROOT CAUSE FOR THE DISPLAY FAILURE). AND THE ROTATIONAL SPEED IS NOT DISPLAYED - BURR SPEED SOUNDS NORMAL. THE DEVICE HISTORY RECORDS (DHR) REVIEW WAS COMPLETED. NO ISSUES WERE FOUND IN THE DHR WERE FOUND THAT WOULD HAVE LED TO REPORTED FAILURE. GIVEN THE AGE OF THE CONSOLE, THE MOST PROBABLE ROOT CAUSE FOR THE FAILURE IS NORMAL WEAR AND TEAR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A ROTATIONAL ATHERECTOMY PROCEDURE, THERE WERE DISPLAY ISSUES. THE RPMS DID NOT DISPLAY ON THE ROTABLATOR CONSOLE, HOWEVER THE SYSTEM STARTED WITHOUT ANY ERROR MESSAGES. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A ROTATIONAL ATHERECTOMY PROCEDURE, THERE WERE DISPLAY ISSUES. THE RPMS DID NOT DISPLAY ON THE ROTABLATOR CONSOLE, HOWEVER THE SYSTEM STARTED WITHOUT ANY ERROR MESSAGES. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT 22020-028-L

    Patients

    Seq Age Sex Outcome Treatment
    1