BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1080645 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02004
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 23, 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

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A DEVICE HISTORY REVIEW CONFIRMS THAT THIS DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE BALLOON RUPTURE CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT DUE TO THE ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE ANATOMY LOCATION, VESSEL AND LESION CHARACTERISTICS ARE UNKNOWN. THE 2.5MM X 20MM MAVERICK 2 MONORAIL CATHETER WAS ADVANCED TO THE LESION AND WAS REPORTED TO HAVE RUPTURED AT 14 (ATMS) ATMOSPHERES OF PRESSURE. IT IS UNKNOWN DURING WHICH INFLATION THE EVENT OCCURRED, NOR THE DURATION AND NUMBER OF INFLATIONS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION WAS 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 20 / 2.5 9059172

    Patients

    Seq Age Sex Outcome Treatment
    1