BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1172348 · Received September 19, 2008

    Report

    Report Number
    2134265-2008-02737
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME AS CASE #2134265-2008-02735. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY ANGIOPLASTY, INFLATION DIFFICULTIES WERE ENCOUNTERED. THE 45% STENOTIC AND MILDLY CALCIFIED AND MILDLY TORTUOUS LESION WAS LOCATED IN THE PROXIMAL SEGMENT OF AN UNSPECIFIED VESSEL. THE 20MM X 15MM MAVERICK 2 MONORAIL CATHETER WAS ADVANCED TO THE LESION. THE FIRST INFLATION WAS ATTEMPTED AT 6 ATM'S, HOWEVER, IT WAS OBSERVED THAT THE BALLOON DID NOT INFLATE AND CONTRAST WAS LEAKING FROM THE BALLOON. NO DIFFICULTIES WITH WITHDRAWAL WERE REPORTED. UPON VISUAL INSPECTION AFTER REMOVAL FROM THE PATIENT, THE PHYSICIAN OBSERVED A "PORE" IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION WAS 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 20 / 1.5 0011493251

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR