BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1012507 · Received March 12, 2008

    Report

    Report Number
    2134265-2008-00736
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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 "NOT VERY TORTUOUS", NON -CALCIFIED AND "80 - 90%" STENOTIC MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 3.0X20MM MAVERICK2 BALLOON TO THE LESION AND INFLATED IT TO 12 - 15ATMS ON THE SECOND INFLATION AND THE BALLOON RUPTURED. THERE WERE NO PT COMPLICATIONS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF A DRUG ELUTING STENT. PT STATUS IS REPORTED AS "FINE".

    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 / 3.0 11329401

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR