BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1181670 · Received September 30, 2008

    Report

    Report Number
    2134265-2008-02836
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE 70% STENOSED LESION WAS LOCATED IN THE MODERATELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 1.5X20MM MAVERICK2 MONORAIL BALLOON CATHETER DID NOT INFLATE AND THE PHYSICIAN REMOVED THE DEVICE AND FOUND THE BALLOON HAD BURST. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAVERICK BALLOON SAME SIZE. THE PATIENT STATUS IS GOOD WITH NO COMPLICATIONS REPORTED.

    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 MAVERICK2 20 /1.5 0011577210

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR