BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 828055 · Received February 9, 2007

    Report

    Report Number
    6000093-2007-00306
    Event Type
    Malfunction
    Date Received
    February 9, 2007
    Date of Event
    January 5, 2007
    Report Date
    January 11, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8860827 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE MAVERICK2 MONORAIL BALLOON RUPTURED AT 14 ATMS ON THE SECOND INFLATION. THE FIRST INFLATION WAS ALSO PERFORMED TO 14 ATMS. THE HEAVILY CALCIFIED LESION WAS LOCATED IN THE CIRCUMFLEX (CX) CORONARY ARTERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO LOX BOSTON SCIENTIFIC MAVERICK2 12/2.5 8860827

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR