BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 3161539 · Received May 5, 2013

    Report

    Report Number
    2017233-2013-00355
    Event Type
    Injury
    Date Received
    May 5, 2013
    Date of Event
    May 26, 2013
    Report Date
    June 3, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT/SERIAL NUMBER IS UNK. A REVIEW OF THE MFG RECORDS FOR THE DEVICE COULD NOT BE COMPLETED. FURTHER INFO WAS REQUESTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT WAS TREATED FOR A RUPTURED AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE PROCEDURE A 12 FR DILATOR WAS INADVERTENTLY USED WITH A 18 FR GORE DRYSEAL SHEATH, AND THE GAP BETWEEN THE SHEATH AND DILATOR CAUSED A TEAR IN THE VASCULATURE (LOCATION UNK) AND BLOOD LOSS (AMOUNT UNK). NO SEQUELAE HAS BEEN REPORTED. FURTHER INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196178 GORE DRYSEAL SHEATH DYB/INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES,INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O