BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2123113 · Received June 14, 2011

    Report

    Report Number
    2134265-2011-02505
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    October 7, 2010
    Report Date
    May 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED THE CUSTOMER APPLIED LABELS TO THE CONSOLE. THE TURBINE CONTROL KNOB WAS MISSING, THE ASSEMBLY WAS FOUND INSIDE THE CONSOLE. THE TURBINE CONTROL ASSEMBLY CABLE WAS TWISTED. ONE OF THE FEET IS MISSING. FUNCTIONAL TESTING ON THE CONSOLE COULD NOT BE CARRIED OUT AS THE TURBINE KNOB ASSEMBLY WAS MISSING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THERE WERE ISSUES WITH THE TURBINE PRESSURE KNOB. THE ROTABLATOR CONSOLE TURBINE PRESSURE KNOB WAS TURNED TO THE MAXIMUM LEVEL, HOWEVER IT WAS NOTED THAT THE KNOB "RETURNED A LITTLE AUTOMATICALLY" FROM THE MAXIMUM SETTING. NO ISSUE WAS NOTED WITH THE ROTATIONAL FREQUENCY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THERE WERE ISSUES WITH THE TURBINE PRESSURE KNOB. THE ROTABLATOR CONSOLE TURBINE PRESSURE KNOB WAS TURNED TO THE MAXIMUM LEVEL, HOWEVER IT WAS NOTED THAT THE KNOB "RETURNED A LITTLE AUTOMATICALLY'' FROM THE MAXIMUM SETTING. NO ISSUE WAS NOTED WITH THE ROTATIONAL FREQUENCY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THERE WERE ISSUES WITH THE TURBINE PRESSURE KNOB. THE ROTABLATOR CONSOLE TURBINE PRESSURE KNOB WAS TURNED TO THE MAXIMUM LEVEL, HOWEVER IT WAS NOTED THAT THE KNOB "RETURNED A LITTLE AUTOMATICALLY" FROM THE MAXIMUM SETTING. NO ISSUE WAS NOTED WITH THE ROTATIONAL FREQUENCY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT H802220200391 RC107849

    Patients

    Seq Age Sex Outcome Treatment
    1