BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2822037 · Received November 7, 2012

    Report

    Report Number
    2134265-2012-06824
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE CONSOLE WAS TESTED USING A GOLD TEST FOOT PEDAL AND 1.75MM ROTALINK BURR. THE ROTATIONAL SPEED IN DYNAGLIDE MODE WAS 85 KRPM; THE MAXIMUM TURBINE ROTATIONAL SPEED REACHED WAS 219 KRPM. THESE ARE TYPICAL OPERATIONAL SPEEDS. THE CONSOLE ROTATIONAL SPEED ABRUPTLY DROPS APPROXIMATELY 58 KRPM FROM MAXIMUM OF 219 KRPM. THE ROTATIONAL SPEED CONTROL IS LINEAR WHEN INCREASING RPMS FROM MINIMUM TO MAXIMUM. 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 PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THERE WAS NO DIGITAL DISPLAY TIMER. THIS ROTA CONSOLE WAS SELECTED; HOWEVER,DURING THE PROCEDURE THE DIGITAL DISPLAY TIMER DIDN'T DISPLAY FOR 15-30 SECONDS WHEN THE FOOT PEDAL WAS ACTIVATED FOR A TEST RUN OUTSIDE THE PATIENT. EVENTUALLY, THE DISPLAY TIMER WORKED WITHOUT ANY ISSUES THROUGHOUT THE CASE. IT WAS FURTHER REPORTED THAT THE CONSOLE MADE SOME IRREGULAR NOISE THROUGHOUT THE PROCEDURE. THE AIR SUPPLY WAS SET AT 6.5 BAR (KPA) AND A FULL AIR TANK WAS USED. THE AIR TUBING WAS EXAMINED FOR DAMAGE AND NO DAMAGE WAS FOUND. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THERE WAS NO DIGITAL DISPLAY TIMER. THIS ROTA CONSOLE WAS SELECTED; HOWEVER,DURING THE PROCEDURE THE DIGITAL DISPLAY TIMER DIDN'T DISPLAY FOR 15-30 SECONDS WHEN THE FOOT PEDAL WAS ACTIVATED FOR A TEST RUN OUTSIDE THE PATIENT. EVENTUALLY, THE DISPLAY TIMER WORKED WITHOUT ANY ISSUES THROUGHOUT THE CASE. IT WAS FURTHER REPORTED THAT THE CONSOLE MADE SOME IRREGULAR NOISE THROUGHOUT THE PROCEDURE. THE AIR SUPPLY WAS SET AT 6.5 BAR (KPA) AND A FULL AIR TANK WAS USED. THE AIR TUBING WAS EXAMINED FOR DAMAGE AND NO DAMAGE WAS FOUND. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802220200381 RC107484

    Patients

    Seq Age Sex Outcome Treatment
    1