BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 806788 · Received January 9, 2007

    Report

    Report Number
    6000089-2007-00048
    Event Type
    Malfunction
    Date Received
    January 9, 2007
    Date of Event
    December 8, 2006
    Report Date
    December 11, 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 WAS NOT RETURNED FOR REVIEW, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE MFG RECORDS FOR TOP ASSEMBLY BATCH # 9123431 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION.

    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 CALCIFIED, 99% STENOSED, PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE BALLOON RUPTURED AT 10 ATMS. THE NUMBER OF INFLATIONS AND TO WHAT ATMS IS UNK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WERE NO REPORTED PT COMPLICATIONS. PT STATUS LISTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOU LOX BOSTON SCIENTIFIC MAVERICK2 12/3.0 0009123431

    Patients

    Seq Age Sex Outcome Treatment
    1 *