BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3030519 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-02119
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CONSOLE AND FOOT PEDAL WERE VISUALLY EXAMINED. THE FOOT PEDAL COULD NOT BE TESTED AS THE DYNAGLIDE CONNECTER IS MISSING. THE CONSOLE COULD NOT BE TESTED AS THE TURBINE PRESSURE CONTROL ASSEMBLY WAS LOOSE. THE OPERATOR(S) KEPT TURNING THE KNOB, CAUSING THE ENTIRE TURBINE CONTROL ASSEMBLY TO ROTATE. THE ASSEMBLY CABLING WOUND UP AND EVENTUALLY THE ASSEMBLY CONNECTOR DISCONNECTED FROM THE MAIN CONTROL PCA BOARD AND THE CONNECTOR WAS DAMAGED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY INTERVENTION PROCEDURE THE DIAL ON THE ROTABLATOR CONSOLE WAS DEFECTIVE. THE KNOB COULD BE TURNED IN EITHER DIRECTION WITHOUT CHANGING THE SPEED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY INTERVENTION PROCEDURE THE DIAL ON THE ROTABLATOR CONSOLE WAS DEFECTIVE. THE KNOB COULD BE TURNED IN EITHER DIRECTION WITHOUT CHANGING THE SPEED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133514 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802220200361 RC107770

    Patients

    Seq Age Sex Outcome Treatment
    1