BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL SHEATH

    MDR report key: 3813102 · Received May 15, 2014

    Report

    Report Number
    2017233-2014-00248
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 29, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THIS PATIENT WAS TREATED FOR A PENETRATING AORTIC ULCER WITH A INTRAMURAL HEMATOMA USING A CONFORMABLE GORE TAG DEVICE. A FEMORAL ARTERY WAS USED AS MAIN ACCESS, HOWEVER, USE OF THE 24 FR GORE DRYSEAL SHEATH WITH HYDROPHILIC COATING RESULTED IN INJURY TO THE FEMORAL ARTERY. THE VESSEL DAMAGE WAS REPAIRED AND A COMMON ILIAC CONDUIT WAS PERFORMED TO COMPLETE THE PROCEDURE. A TGE373715 WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290874 GORE® DRYSEAL SHEATH INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES 11958567

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention