BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1904544 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05378
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE WAS NOT RETURNED TO SITE FOR INVESTIGATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2010-05322. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), SPEED ISSUES OCCURRED. THE 98% STENOSED LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY (RCA) ARTERY. DURING PREP THE ROTABLATOR CONSOLE AND THE 1.25MM ROTABLATOR ROTALINK PLUS PLATFORMED AT 160,000RPMS. THE PHYSICIAN ADVANCED THE ROTALINK PLUS AND SUCCESSFULLY COMPLETED FIVE TO SIX ABLATIONS WITH EACH ABLATION APPROXIMATELY 20-30 SECONDS LONG. THE RPM SPEED THEN BEGAN TO FLUCTUATE ABOVE AND BELOW THE DESIRED SPEEDS. THE SPEED WOULD DECREASE TO 40,000-50,000 RPMS AND THEN INCREASE UP TO 150,000 RPMS. THE PHYSICIAN THOUGHT HE HEARD AN AIR LEAK. AFTER THE FIRST SPEED FLUCTUATION, THE SPEED WAS READJUSTED TO 160,000 RPMS HOWEVER, THE BURR STALLED. AFTER THE SECOND SPEED FLUCTUATION, THE SPEED WAS READJUSTED TO 160,000 RPMS HOWEVER; THE PHYSICIAN OPTED TO DYNAGLIDE OUT DUE TO THE SPEED CONTINUING TO FLUCTUATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020

    Patients

    Seq Age Sex Outcome Treatment
    1