BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3954744 · Received July 24, 2014

    Report

    Report Number
    2134265-2014-04310
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    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 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 MANUFACTURER: DEVICE WAS RETURNED FOR ANALYSIS. THE CONSOLE AND FOOT PEDAL WERE TESTED USING A ROTALINK 1.75MM BURR. THE ROTATIONAL SPEED IN DYNAGLIDE MODE WAS 69 RPM; THE MAXIMUM TURBINE ROTATIONAL SPEED REACHED WAS 219 RPM; THE TURBINE SPEED WAS SET TO AND MAINTAINED 170 RPM. THESE ARE TYPICAL OPERATIONAL SPEEDS. HOWEVER, THE TURBINE ROTATIONAL SPEED CONTROL IS NONLINEAR 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. IN THE CASE OF THIS CONSOLE, THE ROTATIONAL SPEED ABRUPTLY DROPS TO 160 RPM FROM MAXIMUM OF 219 RPM. THE ROTATIONAL SPEED CONTROL IS LINEAR WHEN INCREASING RPMS FROM MINIMUM TO MAXIMUM. 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 HAS BEEN DETERMINED TO BE WEAR AND TEAR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSTABLE SPEED OCCURRED. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WAS SELECTED FOR USE IN A NON-CLINICAL SHAM OPERATION. DURING TESTING OUTSIDE OF THE PATIENT, THE NUMBER OF REVOLUTIONS DID NOT READILY GO DOWN WHEN THE OPERATOR TURNED THE TURBINE PRESSURE ADJUSTMENT KNOB TO 180,000RPM FROM 220,000RPM, WITH NO LOAD. LATER, THE TURBINE PRESSURE GAUGE WENT DOWN SUDDENLY TO 130,000RPM AT A STRETCH, TOO. THE KNOB WAS THEN SET TO 180,000RPM AND THE FOOT PEDAL WAS OFF. AFTER ACTIVATING THE FOOT PEDAL, IT WAS NOTED THAT THE NUMBER OF REVOLUTIONS HAD BECOME 210,000 RPM. NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSTABLE SPEED OCCURRED. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WAS SELECTED FOR USE IN A NON-CLINICAL SHAM OPERATION. DURING TESTING OUTSIDE OF THE PATIENT, THE NUMBER OF REVOLUTIONS DID NOT READILY GO DOWN WHEN THE OPERATOR TURNED THE TURBINE PRESSURE ADJUSTMENT KNOB TO 180,000RPM FROM 220,000RPM, WITH NO LOAD. LATER, THE TURBINE PRESSURE GAUGE WENT DOWN SUDDENLY TO 130,000RPM AT A STRETCH, TOO. THE KNOB WAS THEN SET TO 180,000RPM AND THE FOOT PEDAL WAS OFF. AFTER ACTIVATING THE FOOT PEDAL, IT WAS NOTED THAT THE NUMBER OF REVOLUTIONS HAD BECOME 210,000 RPM. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433342 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802220200391

    Patients

    Seq Age Sex Outcome Treatment
    1