BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2072201 · Received April 28, 2011

    Report

    Report Number
    2134265-2011-01611
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: OVER THE AGE OF 18. EVALUATED BY MFR: 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 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).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2011-01614. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. ACCESS WAS GAINED THROUGH THE FEMORAL ARTERY. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 1.25MM ROTALINK BURR WHICH WAS USED 4 TIMES AT 160,000 RPM. AT THE END OF THE PROCEDURE, WHILE IN DYNAGLIDE MODE, THERE WAS "UNUSUAL" GUIDE WIRE ROTATION NOTICED. WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE GUIDE WIRE HE FELT NO RESISTANCE, BUT NOTICED THAT THE DISTAL TIP OF THE GUIDE WIRE HAD BROKEN OFF AND WAS MISSING. ON A SECOND ANGIOGRAM, IT WAS CLEAR THAT ABOUT 8CM OF THE DISTAL TIP WAS VISIBLE INSIDE THE DIAGONAL ARTERY. THE PIECE OF THE DETACHED GUIDE WIRE REMAINS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS STABLE, HOWEVER, THE PATIENT WILL REMAIN ON DUAL ANTIPLATELET THERAPY INDEFINITELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680020

    Patients

    Seq Age Sex Outcome Treatment
    1