BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDDICK

    MDR report key: 1070778 · Received June 26, 2008

    Report

    Report Number
    1070778
    Event Type
    Malfunction
    Date Received
    June 26, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 26, 2008
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE REDDICK CATHETER WOULD NOT FIT DOWN THE INTRODUCER WITHOUT BREAKING THE BALLOON. ANOTHER CATHETER WAS OPENED WITH LOT# RST1251, AND THE BALLOON BROKE ON THE CATHETER AGAIN WHEN IT ADVANCED DOWN THE INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDDICK CATHETER, CHOLANGIOGRAM GBZ LEMAITRE VASCULAR, INC. * RST1251

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR