BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 7491976 · Received May 7, 2018

    Report

    Report Number
    2134265-2018-03907
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    April 16, 2018
    Report Date
    April 16, 2018
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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 MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION CONCLUSION IS DEVICE NOT RETURNED AS THE COMPLAINT DID NOT INCLUDE RETURNED DEVICE REVIEW AND LACKED THE OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS OF THE EVENT REQUIRED TO DETERMINE WHAT COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 213425-2018-03906 AND 2134265-2018-03905. 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 ROTABLATOR 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
    333343 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - MAPLE GROVE UNK376

    Patients

    Seq Age Sex Outcome Treatment
    1