BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1193277 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02930
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLAIN OLD BALLOON ANGIOPLASTY PROCEDURE, A SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MID LEFT CIRCUMFLEX (LCX). THE 15/2.5MM MAVERICK2 MONORAIL BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR PREDILATION BUT WAS UNABLE TO CROSS DUE TO THE LESION BEING VERY TORTUOUS. WHEN WITHDRAWING THE DEVICE, THE PHYSICIAN EXPERIENCED WITHDRAWAL DIFFICULTY AND THE BALLOON CATHETER BROKE AT MID SHAFT INSIDE OF THE PATIENT. THE DEVICE WAS SUCCESSFULLY REMOVED WITH A SNARE AND THE PROCEDURE WAS ENDED. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 15/2.5MM 11848517

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR