BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1180966 · Received September 29, 2008

    Report

    Report Number
    2134265-2008-02823
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN THE TORTUOUS CIRCUMFLEX CORONARY ARTERY. THE LESION WAS CALCIFIED AND THE DEGREE OF THE STENOSIS IS UNKNOWN. THE MAVERICK 12MM X 2.0MM BALLOON CATHETER WAS ADVANCED TO THE LESION FOR PREDILATION. HOWEVER, UPON INFLATION, THE BALLOON RUPTURED AT 8 ATMS. THE NUMBER OF INFLATIONS AND TO WHAT ATMS AND THE DURATION IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH AN 11MM X 2.5MM BALLOON FROM AN UNSPECIFIED MANUFACTURER. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S 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 12 / 2.0 11563229

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 0.14 RINATO WIRE| 2.0MM X 8MM BALLOON| BMW WIRE