BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1180983 · Received September 29, 2008

    Report

    Report Number
    2134265-2008-02826
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN AN EXTREMELY TORTUOUS AND CALCIFIED FIRST DIAGONAL BRANCH. A 2.5X12MM MAVERICK2 MONORAIL BALLOON WAS USED FOR A PRE AND POST DILATATION. ON THE SECOND INFLATION, THE BALLOON WAS INFLATED FOR 10 SECONDS AND RUPTURED AT AN UNKNOWN ATMOSPHERE. THE ATMOSPHERES AND DURATION OF THE FIRST INFLATION ARE UNKNOWN. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 12 / 2.5 11655204

    Patients

    Seq Age Sex Outcome Treatment
    1