BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 811417 · Received January 10, 2007

    Report

    Report Number
    6000089-2007-00061
    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 S201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS CONFIRMED THAT THE DEVICE HAS BEEN DISPOSED, SO NO PRODUCT ANALYSIS IS POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS FOR BATCH 7952482 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 MAVERICK 2 MONORAIL BALLOON RUPTURED. THE LESION BEING TREATED WAS LOCATED IN THE 90% STENOSED, CALCIFIED AND SEVERELY TORTUOUS LEFT CIRCUMFLEX ARTERY (LCX). THE MAVERICK 2 BALLOON RUPTURED AT 10 ATMS ON THE 4TH INFLATION. THE FIRST THREE INFLATIONS WERE TO 12 ATMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICES. PATIENTS STATUS WAS REPORTED 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 20/1.5 7952482

    Patients

    Seq Age Sex Outcome Treatment
    1 *