BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2020725 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00693
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    February 16, 2011
    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

    DEVICE EVALUATED BY MFR: THE INITIAL CONDITION OF THE RECEIVED CONSOLE WAS: VOID SEAL BROKEN, CUSTOMER LABEL ON COVER, TAPE ON COVER, GAS/AIR SUPPLY INLET CONNECTOR IS LOOSE, MISSING ONE RUBBER FOOT, FIBER OPTIC RETRAINING LATCH IS BROKEN. THE CONSOLE COULD NOT BE TESTED - THE POWER SUPPLY WAS DEFECTIVE. THE TURBINE PRESSURE GAUGE EXHIBITED MASSIVE FLUCTUATION AND THE PRESSURE SWITCHES WERE CONSTANTLY SWITCHING STATE (OPENING AND CLOSING). THE POWER SUPPLY WAS VISUALLY EXAMINED, BUT THERE WAS NO EVIDENCE OF DAMAGE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A ROTATIONAL ATHERECTOMY PROCEDURE, DISPLAY ISSUES WERE ENCOUNTERED. THE RPM DISPLAY ON THE ROTABLATOR CONSOLE AS WELL AS THE DYNAGLIDE MODE SIGNAL WERE INTERMITTENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR A ROTATIONAL ATHERECTOMY PROCEDURE, DISPLAY ISSUES WERE ENCOUNTERED. THE RPM DISPLAY ON THE ROTABLATOR CONSOLE AS WELL AS THE DYNAGLIDE MODE SIGNAL WERE INTERMITTENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND STATUS IS OK.

    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