BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCA EPIDURAL INTRODUCER

    MDR report key: 558521 · Received October 5, 2004

    Report

    Report Number
    MW1033338
    Event Type
    Malfunction
    Date Received
    October 5, 2004
    Date of Event
    August 24, 2004
    Report Date
    September 27, 2004
    Manufacturer
    EPIMED INTERNATIONAL
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INDRODUCER CATHETER PLACED VIA SACRAL HIATUS TO CAUDAL EPIDURAL SPACE IN ORDER TO PERFORM EPIDUROLYSIS PROCEDURE AND EPIDURAL STEROID INJECTION. INTRODUCER CATHETER DID NOT COME OUT EASILY AT THE END OF THE PROCEDURE. THE CATHETER STRECHED OUT WHILE BEING REMOVED, AND SEEMED THAT IT WOULD NOT BE ABLE TO BE TAKEN OUT WITHOUT BREAKING AND LEAVING THE TIP IN THE PT. A SMALL CUT WAS MADE IN THE SKIN AROUND THE CATHETER, AND THE CATHETER WAS GRABBED WITH A HEMOSTAT IN ORDER TO REMOVE IT WHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCA EPIDURAL INTRODUCER CATHETER OVER EPIDURAL NEEDLE FOR USE WITH RACZ EPIDUROLYSIS BSO EPIMED INTERNATIONAL * 1240812

    Patients

    Seq Age Sex Outcome Treatment
    1 * EPIMED BREVI-XL RADIO-OPAQUE EPIDURAL CATHETER.