BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1083384 · Received July 28, 2008

    Report

    Report Number
    2134265-2008-02106
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE A BALLOON PERFORATION OCCURRED. THE 75% STENOTIC CONCENTRIC SHAPED LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN ADVANCED THE 2.0X15MM MAVERICK2 BALLOON CATHETER TO THE LESION AND ATTEMPTED TO INFLATE IT TO 4ATMS, BUT NOTICED THAT THE BALLOON DID NOT INFLATE BECAUSE THERE WAS A PERFORATION AND CONTRAST MEDIUM WAS LEAKING OUT THROUGH THE PUNCTURE. THERE WERE NO PT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.0X15MM MAVERICK2 BALLOON CATHETER AND THE DEPLOYMENT OF A STENT. PATIENT STATUS IS REPORTED AS "STABLE".

    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 15/2.0 11695906

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR RUNWAY FL4 6 FR| CHOICE FLOPPY GUIDEWIRE