BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1022485 · Received March 31, 2008

    Report

    Report Number
    2134265-2008-00924
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P86009/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 INTERVENTIONAL (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 95% STENOTIC LESION WAS LOCATED IN THE CALCIFIED AND TORTUOUS MID RIGHT CORONARY ARTERY (RCA). THE 15MM X 3.0MM MAVERICK2 MONORAIL BALLOON RUPTURED AS A PINHOLE AT 6 ATMS ON THE SECOND INFLATION. THE FIRST INFLATION WAS ALSO PERFORMED TO 6 ATMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PT COMPLICATIONS WERE REPORTED. 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 15/3.0 7795920

    Patients

    Seq Age Sex Outcome Treatment
    1 HIRYU BALLOON CATHETER