BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTIMUM HEMOSTASIS INTRODUCER, 6F ACT, 12CM SHEATH

    MDR report key: 460297 · Received May 13, 2003

    Report

    Report Number
    2182269-2003-00062
    Event Type
    Other
    Date Received
    May 13, 2003
    Date of Event
    April 8, 2003
    Report Date
    May 13, 2003
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DILATOR TIP WAS SPLIT AND CAUSED DAMAGE TO THE VESSEL. MEDICATION WAS ADMINISTERED TO THE VESSEL TO RESOLVE THE TRAUMA. THE PHYSICIAN USED THE OPPOSITE ARM TO OBTAIN RADIAL ACCESS TO COMPLETE THE PROCEDURE. IT WAS ALSO NOTED THE VESSEL WAS NOT SEVERELY INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMUM HEMOSTASIS INTRODUCER, 6F ACT, 12CM SHEATH ULTIMUM INTRODUCER DYB ST. JUDE MEDICAL, DAIG DIVISION, INC. NA 02DP97

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other MEDICATION (TYPE UNKNOWN) 2003.