BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1032600 · Received April 22, 2008

    Report

    Report Number
    2134265-2008-01154
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 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 TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, A 2.0 X 20 MM MAVERICK2 MONORAIL BALLOON RUPTURED. THE 80% STENOSED LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT CIRCUMFLEX. ON THE FIRST INFLATION, THE BALLOON WAS INFLATED FOR 1 SECOND AT 12 ATMOSPHERES AND RUPTURED. THE BALLOON WAS REMOVED INTACT. THE BALLOON WAS PARTIALLY VISIBLE UNDER FLUOROSCOPY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PT STATUS IS 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 MAVERICK2 20/2.0 9428045

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR