BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 860822 · Received March 8, 2007

    Report

    Report Number
    6000089-2007-00342
    Event Type
    Malfunction
    Date Received
    March 8, 2007
    Date of Event
    February 8, 2007
    Report Date
    February 8, 2007
    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

    A UNIT HAS NOT BEEN 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 COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH #9232753, 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 99% STENOSED LESION WAS LOCATED IN THE CALCIFIED, PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PHYSCIAN FOUND IT DIFFICULT TO CROSS THE LESION TO PRE-DILATE. THE BALLOON WAS ABLE TO CROSS, BUT RUPTURED DURING THE INITIAL INFLATION TO 10 ATMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S BALLOON, AND DEPLOYMENT OF A LIBERTE' STENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS. PATIENT 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, PERCUTANEO LOX BOSTON SCIENTIFIC MAVERICK2 15/1.5 9232753

    Patients

    Seq Age Sex Outcome Treatment
    1 * BALLOON: RYUJIN PLUS 1.5MM