BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1822933 · Received September 1, 2010

    Report

    Report Number
    2134265-2010-04055
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    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

    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

    UPDATED: EVALUATION SUMMARY ATTACHED, DEVICE EVALUATED BY MANUFACTURER, METHOD CODES, RESULT CODES, CONCLUSION CODES, DEVICE AVAILABLE FOR EVALUATION, RETURN TO MANUFACTURER ON, DEVICE RETURNED TO MANUFACTURER. DEVICE EVALUATED BY MANUFACTURER: THE CONSOLE AND FOOT PEDAL WERE TESTED TOGETHER USING A ROTALINK 1.75MM BURR. THE ROTATIONAL SPEED IN DYNAGLIDE MODE WAS 68 KRPM; IN TURBINE MODE, THE SPEED WAS SET TO AND MAINTAINED 180 KRPM AND 190 KRPM; THE MAXIMUM TURBINE ROTATIONAL SPEED REACHED WAS 210 KRPM. THESE ARE TYPICAL OPERATIONAL SPEEDS. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, SPEED ISSUES WERE ENCOUNTERED. THE LOCATION OF THE LESION IS UNKNOWN. FOLLOWING A SUCCESSFUL ABLATION WHILE REMOVING THE BURR IN DYNAGLIDE, UNUSUALLY HIGH RPM'S WERE NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, SPEED ISSUES WERE ENCOUNTERED. THE LOCATION OF THE LESION IS UNKNOWN. FOLLOWING A SUCCESSFUL ABLATION WHILE REMOVING THE BURR IN DYNAGLIDE, UNUSUALLY HIGH RPM'S WERE NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S 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 22020-039-R

    Patients

    Seq Age Sex Outcome Treatment
    1