BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK CATHETER

    MDR report key: 1150256 · Received September 3, 2008

    Report

    Report Number
    2134265-2008-02516
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    June 30, 2008
    Report Date
    August 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE DEVICE HISTORY RECORD REVIEW OF POSSIBLE BATCHES CONFIRMS THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE CLASSIFICATION FOR THE EVENT DESCRIPTION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A VESSEL SHUTDOWN OCCURRED. THE PT HAD BEEN CONSIDERED FOR BYPASS SURGERY BUT WAS CONSIDERED TOO HIGH-RISK. THE MODERATELY TORTUOUS LESION BEING TREATED WAS LOCATED IN THE HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) IN AN ANEURISMAL SEGMENT. ANOTHER MANUFACTURER'S STENT WAS ATTEMPTED TO CROSS THE LESION WITHOUT SUCCESS. A BALLOON WAS THEN TRIED TO PREDILATE THE LESION WITHOUT SUCCESS. AN INITIAL ABLATION RUN WITH THE 1.50MM BURR WAS MADE AT AN UNK SPEED FOR 20 SECONDS. THE VESSEL THEN SHUT DOWN. A BALLOON PUMP WAS INSERTED, AND THE PT WAS PUT ON A VENTILATOR. THE ABLATION WAS THEN CONTINUED WITH A 1.25MM BURR FOR 2 RUNS, AND THEN ORIGINAL 1.5MM BURR WAS THEN USED FOR THREE ABLATION RUNS. PT WAS EXCAVATED THE FOLLOWING MORNING, AND WAS DISCHARGED FROM THE HOSPITAL TWO DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK CATHETER MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CVA21

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization