BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA BALLOON CATHETER

    MDR report key: 824998 · Received October 31, 2006

    Report

    Report Number
    6000089-2006-02354
    Event Type
    Malfunction
    Date Received
    October 31, 2006
    Date of Event
    October 13, 2006
    Report Date
    October 13, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. A REVIEW OF THE MANUFACTURING RECORDS FOR BATCH 8791802 SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. THIS BATCH HAS NO ASSOCIATED COMPLAINTS TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PCI PROCEDURE, THE MAVERICK2 MONORAIL BALLOON RUPTURED AT NOMINAL PRESSURE ON THE FIRST INFLATION. THE LESION WAS LOCATED IN THE 99% STENOTIC, NON-CALCIFIED, AND NON-TORTUOUS PROXIMAL CIRCUMFLEX ARTERY (CX). THERE WERE NO PATIENT COMPLICATIONS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. PATIENT STATUS WAS REPORTED AS 'GOOD.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA BALLOON CATHETER PTCA CATHETER LOX BOSTON SCIENTIFIC 12MM X 2.0MM 0008791802

    Patients

    Seq Age Sex Outcome Treatment
    1 YR