BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIANCE II INTEGRATED INFLATION SYSTEM

    MDR report key: 1062028 · Received June 13, 2008

    Report

    Report Number
    3005099803-2008-00719
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAV
    PMA / PMN Number
    K922573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE STATED IN THE EVENT DESCRIPTION IS PTCA. FURTHER CLARIFICATION IS NOT AVAILABLE FROM THE USER FACILITY IF THIS REFERS TO PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (FOR WHICH THIS DEVICE IS NOT INDICATED). THE SUSPECT DEVICE HAS BEEN RETURNED, BUT THE EVALUATION IS NOT COMPLETE; THEREFORE, THE CAUSE OF THE REPORTED DIFFICULTIES HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    AN ALLIANCE II INTEGRATED INFLATION SYSTEM WAS USED DURING A PTCA PROCEDURE. THE COMPLAINANT STATED THAT "SOMETIMES THE ALLIANCE II INFLATION / LITHO DEVICE WORKS AND SOMETIMES IT [DOESN'T]." ACCORDING TO THE COMPLAINANT, THE REPORTED DIFFICULTIES WERE ENCOUNTERED OUTSIDE OF THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE (PRODUCT AND MANUFACTURER UNKNOWN). THERE IS NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLIANCE II INTEGRATED INFLATION SYSTEM MAV BOSTON SCIENTIFIC CORPORATION M00550620 0000030821

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK