BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2123400 · Received June 14, 2011

    Report

    Report Number
    2134265-2011-02411
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 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 MFR.: THE CONSOLE AND FOOT PEDAL WERE RECEIVED. THE CONSOLE WAS TESTED WITH A TEST FOOT PEDAL AND A 1.75MM ROTALINK BURR. NO ROTATIONAL SPEED WAS OBTAINED IN TURBINE OR DYNAGLIDE MODES. A MASSIVE GAS/AIR LEAK WAS NOTED AT THE TURBINE PRESSURE SWITCH. VISUAL INSPECTION OF THE FOOT PEDAL IDENTIFIED THE DYNAGLIDE CONNECTOR O-RING WAS BROKEN AND THERE WAS SCORING ON THE CONNECTOR TIP. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS WEAR AND TEAR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE ROTATIONAL SPEED DISPLAY DID NOT FUNCTION. DURING PREPARATION, THE ROTABLATOR CONSOLE WAS UNABLE TO DISPLAY THE ROTATIONAL SPEED OR MINUTE VALUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS THE DEVICE HAD NO CONTACT WITH THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE ROTATIONAL SPEED DISPLAY DID NOT FUNCTION. DURING PREPARATION, THE ROTABLATOR CONSOLE WAS UNABLE TO DISPLAY THE ROTATIONAL SPEED OR MINUTE VALUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS THE DEVICE HAD NO CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT 22020-038-L

    Patients

    Seq Age Sex Outcome Treatment
    1 DYNAGLIDE FOOT PEDAL