BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1924767 · Received December 14, 2010

    Report

    Report Number
    2134265-2010-05571
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE CONSOLE WAS TESTED USING A FOOT PEDAL AND A ROTALINK 1.75MM BURR. THE ROTATIONAL SPEED WAS TESTED IN DYNAGLIDE AND TURBINE MODE AND THE ROTATIONAL SPEED MET SPECIFICATIONS. NO ISSUES WERE NOTED WITH ANY OF THE DISPLAYS FUNCTIONS ON THE CONSOLE; ROTATIONAL SPEED, PROCEDURE TIMER AND EVENT TIME. THE TURBINE ROTATIONAL SPEED CONTROL IS NON-LINEAR WHEN DECREASING FROM MAXIMUM RPMS. THE TURBINE PRESSURE CONTROL KNOB REQUIRES EXTRA TURNS BEFORE THE PRESSURE GAUGE READING REGISTERS A DROP IN PRESSURE AND THE ROTATIONAL SPEED DISPLAY REGISTERS A DROP IN RPMS. THE ROTATIONAL SPEED ABRUPTLY DROPS APPROXIMATELY 62 KRPM FROM MAXIMUM KRPM. THE ROTATIONAL SPEED CONTROL IS LINEAR WHEN INCREASING RPMS FROM MINIMUM TO MAXIMUM. THE ISSUE IS MOST LIKELY DUE TO A FAILURE OF THE PROPORTIONAL VALVE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A ROTATIONAL ATHERECTOMY PROCEDURE, THE ROTATIONAL SPEED DISPLAY FAILED TO LIGHT UP. DURING PREPARATION, THE ROTABLATOR CONSOLE FAILED TO DISPLAY THE REVOLUTION PER MINUTE (RPM), JUST THE POWER LIGHT CAME ON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE DEVICE HAD NO CONTACT WITH THE PATIENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A ROTATIONAL ATHERECTOMY PROCEDURE, THE ROTATIONAL SPEED DISPLAY FAILED TO LIGHT UP. DURING PREPARATION, THE ROTABLATOR CONSOLE FAILED TO DISPLAY THE REVOLUTION PER MINUTE (RPM), JUST THE POWER LIGHT CAME ON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 22020-039-L RC105733

    Patients

    Seq Age Sex Outcome Treatment
    1