BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 12440080 · Received September 8, 2021

    Report

    Report Number
    3007284313-2021-01576
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 10, 2021
    Report Date
    December 7, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630028
    PMA / PMN Number
    K160254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ADDITIONAL MANUFACTURER NARRATIVE: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION CODES. EVALUATION SUMMARY: THE ROOT CAUSE FOR THE INABILITY TO ADVANCE THE GORE® EXCLUDER® AAA ENDOPROSTHESES THROUGH THE GORE® DRYSEAL FLEX INTRODUCER SHEATHS (DFS) COULD NOT BE DETERMINED BECAUSE THE EVENT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) 2021, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFECTED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® DRYSEAL FLEX INTRODUCER SHEATHS (DFS). DURING THE PROCEDURE, THE 16FR DFS WAS INSERTED AND ATTEMPTED TO ADVANCE IN THE RIGHT LEG BUT THE DFS COULD NOT BE ADVANCED. THE SHEATH WAS REMOVED, AND THE PROCEDURE WAS CONTINUED USING ANOTHER 16FR DFS WITHOUT ANY ISSUE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THE ACCESS ROUTE WAS CALCIFIED AND NARROW. THE DISTAL END OF THE REMOVED SHEATH WAS TORN. REPORTEDLY, IT COULD NOT BE DETERMINED WHETHER THE TEAR WAS OCCURRED PRIOR TO THE PROCEDURE OR DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335561 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. DSF1633 00733132630028

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male