BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MONORAIL BALLOON CATHETER

    MDR report key: 1001743 · Received February 19, 2008

    Report

    Report Number
    2134265-2008-00460
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    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 (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS, MODERATELY CALCIFIED AND 90% STENOTIC MID RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED THE 3.5X20MM QUANTUM MAVERICK BALLOON TO THE LESION AND INFLATED THE BALLOON TO 20 ATMS ON THE FIRST INFLATION AND IT RUPTURED. THERE WERE NO PT COMPLICATIONS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 3.5X20MM QUANTUM MAVERICK BALLOON AND THE DEPLOYMENT OF A STENT. PT STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MONORAIL BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 20 / 3.5 9306889

    Patients

    Seq Age Sex Outcome Treatment
    1