BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2143207 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02669
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE ROTABLATOR COMPLAINT ADVANCER UNIT CARRIED OUT FOUND NO ISSUES NOTED WITH THE ADVANCER AIR HOSE, FIBER OPTIC CABLES AND SALINE INFUSION PORT. OTHER FUNCTIONAL TESTING PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION REVEALED NO ISSUES WITH THE UNIT'S HANDSHAKE CONNECTOR. THE ROTABLATOR ADVANCER UNIT WAS WIRE GUIDED USING A TEST GUIDE WIRE. NO ISSUES WERE NOTED DURING THE WIRE GUIDING OF THE DEVICE. THE ROTABLATOR ADVANCER WAS ATTACHED TO A TEST CATHETER AND WET TESTED. A SPEED OF 175KRPM WAS REACHED. THE BRAKE DEFEAT BUTTON WAS TESTED AND NO ISSUE WAS NOTED. THE GUIDEWIRE DID NOT MOVE. THE BRAKE DEFEAT FEATURE WAS DE-ACTIVATED, AND THE GUIDEWIRE COULD BE REMOVED FROM THE DEVICE. NO ISSUE WAS NOTED WITH THE BRAKE OF THE RETURNED ADVANCER UNIT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE A BRAKE MALFUNCTIONED. THE 80% STENOSED LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. THE ROTALINK ADVANCER WITH TUBULAR DRIVE SHAFT WAS BEING UTILIZED DURING BURRING, HOWEVER, IT WAS NOTICED THAT THE DISTAL END OF THE FLOPPY ROTAWIRE GUIDE WIRE WAS MOVING DISTALLY DURING BURR ADVANCEMENT. THE ADVANCER BRAKE DID NOT WORK WHEN THE TURBINE PRESSURE WAS INITIATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE A BRAKE MALFUNCTIONED. THE 80% STENOSED LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. THE ROTALINK ADVANCER WITH TUBULAR DRIVE SHAFT WAS BEING UTILIZED DURING BURRING, HOWEVER, IT WAS NOTICED THAT THE DISTAL END OF THE FLOPPY ROTAWIRE GUIDE WIRE WAS MOVING DISTALLY DURING BURR ADVANCEMENT. THE ADVANCER BRAKE DID NOT WORK WHEN THE TURBINE PRESSURE WAS INITIATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H80222782001A0 14188105

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR