BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3021933 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-02334
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD CODES, RESULTS CODES, CONCLUSION CODES: UPDATED. DEVICE EVALUATED BY MFR: A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED NO ROTATIONAL DISPLAY. THE CONSOLE AND FOOT PEDAL WERE TESTED USING A ROTALINK 1.75MM BURR. THE ROTATIONAL SPEED WAS NOT DISPLAYED DUE TO A MASSIVE GAS/AIR LEAK AT THE TURBINE PRESSURE SWITCH. THE FOOT PEDAL WAS TESTED WITH THE GOLD CONSOLE AND FUNCTIONED PROPERLY, READILY ACTIVATING/DEACTIVATING THE BURR ROTATION AND SWITCHING THE CONSOLE BETWEEN TURBINE AND DYNAGLIDE MODES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS WEAR AND TEAR DUE TO THE AGE OF THE CONSOLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERIODIC MAINTENANCE INSPECTION OF A ROTABLATOR CONSOLE, DISPLAY ISSUE OCCURRED. THERE WAS NO RPM ON THE ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERIODIC MAINTENANCE INSPECTION OF A ROTABLATOR CONSOLE, DISPLAY ISSUE OCCURRED. THERE WAS NO RPM ON THE ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123006 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802220200391

    Patients

    Seq Age Sex Outcome Treatment
    1