BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 811436 · Received January 10, 2007

    Report

    Report Number
    6000089-2007-00060
    Event Type
    Malfunction
    Date Received
    January 10, 2007
    Date of Event
    December 12, 2006
    Report Date
    December 12, 2006
    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 DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED DEVICE IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH #9021633 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. THE ROOT CAUSE OF THE EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCI PROCEDURE, THE MAVERICK2 MONORAIL BALLOON RUPTURED. THE LESION BEING TREATED WAS LOCATED IN THE 99% STENOSED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE MAVERICK2 MONORAIL BALLOON RUPTURED AT 10 ATMS ON THE INITIAL INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAVERICK2 MONORAIL BALLOON. THERE WERE NO REPORTED PATIENT COMPLICATIONS. PATIENT STATUS IS LISTED AS "GOOD".

    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 MAVERICK 15/1.5 9021633

    Patients

    Seq Age Sex Outcome Treatment
    1 *