BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1012505 · Received March 12, 2008

    Report

    Report Number
    2134265-2008-00737
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 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 (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS, CALCIFIED AND 99% STENOTIC LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 2.5X15MM MAVERICK2 BALLOON TO THE LESION AND INFLATED IT TO 10ATMS AND THE BALLOON RUPTURED. THERE WERE NO PT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.5X15MM MAVERICK2 BALLOON. PT STATUS IS REPORTED 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 15/2.5 0011390654

    Patients

    Seq Age Sex Outcome Treatment
    1