BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 7491978 · Received May 7, 2018

    Report

    Report Number
    2134265-2018-03905
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    April 16, 2018
    Report Date
    April 16, 2018
    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: THE ROTABLATOR CONSOLE POWERED UP AND FUNCTIONED PROPERLY PASSING THE ROTABLATOR FUNCTIONAL FEATURE TEST. ADDITIONAL TESTING WAS CARRIED OUT 5 TIMES AND THE SAME RPM OF 105000 RPM WAS ACHIEVED AND REMAINED STEADY AT 105000 RPM FOR 10 SECONDS. THERE WAS NO FLUCTUATION IN SPEED OBSERVED. A SERVICE HISTORY REVIEW WAS PERFORMED AND THERE WERE NO PRIOR SERVICE RECORDS FOUND FOR THIS DEVICE. IN LIEU OF A SERVICE HISTORY REVIEW, A DHR REVIEW WAS PERFORMED AND NOTHING WAS FOUND TO INDICATE A POSSIBLE PROCESS-RELATED CAUSE FOR THE COMPLAINT. THE INVESTIGATION CONCLUSION IS NOT CONFIRMED - RETURNED AS THERE WAS NO EVIDENCE OF EITHER THE ALLEGED ISSUE(S) OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#213425-2018-03906, 213425-2018-03907. IT WAS REPORTED THE SPEED WAS UNSTABLE. DURING PLATFORM TESTING, OUTSIDE OF THE PATIENT, THE ROTABLATOR CONSOLE AND A ROTABLATOR PLUS CATHETER WERE UNABLE TO MAINTAIN A STABLE SPEED. THE PHYSICIAN WANTED TO RUN AT 170,000RPM, BUT THE DEVICE WAS RUNNING BETWEEN 90 TO 220,000RPM. THE ROTBALATOR PLUS CATHETER WAS EXCHANGED FOR A NEW CATHETER AND THE SAME ISSUE OCCURRED. THE PHYSICIAN ALSO STATED THE NOISE DURING THE TEST RUN DIFFERED FROM THE NORMAL SOUND DURING ROTATION. BOTH CATHETERS WERE NOTED TO HAVE BEEN CONTINUOUSLY FLUSHED DURING TESTING. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#213425-2018-03906, 213425-2018-03907. IT WAS REPORTED THE SPEED WAS UNSTABLE. DURING PLATFORM TESTING, OUTSIDE OF THE PATIENT, THE ROTABLATOR CONSOLE AND A ROTABLATOR PLUS CATHETER WERE UNABLE TO MAINTAIN A STABLE SPEED. THE PHYSICIAN WANTED TO RUN AT 170,000RPM, BUT THE DEVICE WAS RUNNING BETWEEN 90 TO 220,000RPM. THE ROTBALATOR PLUS CATHETER WAS EXCHANGED FOR A NEW CATHETER AND THE SAME ISSUE OCCURRED. THE PHYSICIAN ALSO STATED THE NOISE DURING THE TEST RUN DIFFERED FROM THE NORMAL SOUND DURING ROTATION. BOTH CATHETERS WERE NOTED TO HAVE BEEN CONTINUOUSLY FLUSHED DURING TESTING. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333341 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802220200361

    Patients

    Seq Age Sex Outcome Treatment
    1