BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1853084 · Received October 5, 2010

    Report

    Report Number
    2134265-2010-04671
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE CONSOLE AND FOOT PEDAL WERE TESTED USING A ROTALINK 1.75MM BURR. THE ROTATIONAL SPEED IN DYNAGLIDE MODE, AND IN TURBINE MODE WERE TYPICAL OPERATIONAL SPEEDS. THE CONSOLE DID NOT EXHIBIT ANY PROBLEMS WITH THE GAS/AIR SUPPLY INLET CIRCUIT. THE FOOT PEDAL FUNCTIONED PROPERLY, READILY ACTIVATING/DEACTIVATING THE BURR ROTATION AND SWITCHING THE CONSOLE BETWEEN TURBINE AND DYNAGLIDE MODES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE CLASSIFICATION COULD NOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE CONSOLE AIR PRESSURE WAS UNSTABLE. DURING PLATFORM TESTING OF UNSPECIFIED ROTABLATOR DEVICES, THE PHYSICIAN NOTICED THAT THE AIR PRESSURE OF THE ROTABLATOR CONSOLE WAS UNSTABLE. HE PROCEEDED TO CHECK ALL THE ACCESSORIES CONNECTED TO THE CONSOLE AS WELL AS THE CONNECTION OF THE AIR SUPPLY FROM THE WALL AND ALL FUNCTIONED WELL. A NEW CONSOLE WAS USED AND NO ISSUES WERE NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SECOND CONSOLE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE CONSOLE AIR PRESSURE WAS UNSTABLE. DURING PLATFORM TESTING OF UNSPECIFIED ROTABLATOR DEVICES, THE PHYSICIAN NOTICED THAT THE AIR PRESSURE OF THE ROTABLATOR CONSOLE WAS UNSTABLE. HE PROCEEDED TO CHECK ALL THE ACCESSORIES CONNECTED TO THE CONSOLE AS WELL AS THE CONNECTION OF THE AIR SUPPLY FROM THE WALL AND ALL FUNCTIONED WELL. A NEW CONSOLE WAS USED AND NO ISSUES WERE NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SECOND CONSOLE. 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 H802220200381 RC107065

    Patients

    Seq Age Sex Outcome Treatment
    1