BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2083082 · Received May 10, 2011

    Report

    Report Number
    2134265-2011-01845
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE CONSOLE WAS RECEIVED IN GOOD CONDITION - THE REPAIR REPORT DOES NOT INDICATE ANY DAMAGE. FUNCTIONAL CHECK ROTABLATOR CONSOLE WAS TESTED AND THE CONSOLE FUNCTIONED PROPERLY. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE DISPLAY ISSUES OCCURRED. THE ROTABLATOR CONSOLE KIT ASSY UL/CSA WAS BEING TESTED OUTSIDE OF THE PATIENT WHEN IT WAS NOTED THAT THE BURR WOULD ROTATE INTERMITTENTLY AND THE RPM READOUT WAS NOT DISPLAYED ON THE CONSOLE SCREEN. THE PHYSICIAN ATTEMPTED TO TEST THE DEVICES INSIDE OF THE PATIENT WITH THE SAME RESULTS. THE BURR WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED IN A DIFFERENT MANNER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE DISPLAY ISSUES OCCURRED. THE ROTABLATOR CONSOLE KIT ASSY UL/CSA WAS BEING TESTED OUTSIDE OF THE PATIENT WHEN IT WAS NOTED THAT THE BURR WOULD ROTATE INTERMITTENTLY AND THE RPM READOUT WAS NOT DISPLAYED ON THE CONSOLE SCREEN. THE PHYSICIAN ATTEMPTED TO TEST THE DEVICES INSIDE OF THE PATIENT WITH THE SAME RESULTS. THE BURR WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED IN A DIFFERENT MANNER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT H802220200391 RC105766

    Patients

    Seq Age Sex Outcome Treatment
    1