BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR CONSOLE

    MDR report key: 1222848 · Received November 6, 2008

    Report

    Report Number
    2134265-2008-04230
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY ROTATIONAL ATHERECTOMY PROCEDURE, THE OPERATIONAL SPEED COULD NOT BE REDUCED. THE ROTABLATOR CONSOLE WAS INITIALLY RUN AT 210,000 RPMS, HOWEVER WHEN THE PHYSICIAN TRIED TO ADJUST IT TO 200,000, HE WAS UNABLE TO. THEREFORE, THE PROCEDURE WAS COMPLETED AT 210,000 RPMS. THERE WERE NO PT COMPLICATIONS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS DEVICE. PT STATUS WAS REPORTED AS 'FINE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR CONSOLE MCX CATHETER, CORONARY , ATHERECTOMY MCX BOSTON SCIENTIFIC RC5000

    Patients

    Seq Age Sex Outcome Treatment
    1