BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDDICK STIFFER

    MDR report key: 1721522 · Received June 9, 2010

    Report

    Report Number
    1721522
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    June 6, 2010
    Report Date
    June 9, 2010
    Manufacturer
    LEMAITRE VASCULAR INC.
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A COMMON BILE DUCT EXPLORATION AND WANTED TO USE THE REDDICK CHOLANGIOGRAM CATHETER. THE FIRST ONE WAS OPENED AND THE BALLOON WOULD NOT INFLATE. A SECOND ONE WAS OPENED AND THE BALLOON HAD A TEAR IN IT. THIS WAS THE LAST ONE IN THE BOX. A NEW BOX WAS OPENED AND THE CATHETER WORKED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDDICK STIFFER CHOLANGIOGRAM CATHETER GBZ LEMAITRE VASCULAR INC. 2400-51 RED1251
    2 REDDICK STIFFER CHOLANGIOGRAM CATHETER GBZ LE MAITRE VASCULAR 2400-51 RED1251

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR