BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 24307480 · Received February 10, 2026

    Report

    Report Number
    3007284313-2026-04565
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 13, 2026
    Report Date
    March 30, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630042
    PMA / PMN Number
    K160254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. GORE REVIEWED THE RESULTS OF THE REVIEW OF THE DEVICE HISTORY RECORDS PERFORMED BY CREGANNA FOR THE REPORTED LOT NUMBER, WHICH SHOWED THAT THE RELEASE CRITERIA HAD BEEN MET. ENGINEERING EVALUATION OF THE DEVICE IS ANTICIPATED (DEVICE CURRENTLY IN TRANSIT). W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY HAVE NOT BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    UPDATED D9, H3. UPDATED H6: UPDATED HEALTH EFFECT - CLINICAL CODE TO E0506, REMOVED E2403. ADDED HEALTH EFFECT - IMPACT CODE TO F23 AND F1908. ADDED TYPE OF INVESTIGATION CODE B01 AND B11. UPDATED INVESTIGATION FINDINGS CODE TO C0703 AND C24, CODE C21 IS NO LONGER APPLICABLE. UPDATED INVESTIGATION CONCLUSIONS CODE TO D15 AND D12, CODE D16 IS NO LONGER APPLICABLE. THE REPORTED LEAKAGE AND DEFLATION OF THE VALVE WERE CONFIRMED THROUGH AN EVALUATION OF THE RETURNED GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE SHEATH¿S VALVE WAS PRESSURIZED WITH WATER AND IT WAS OBSERVED TO BE LEAKING FROM BOTH ENDS. THE VALVE WAS DECONSTRUCTED AND THERE WAS PARTIAL FEP RING SEPARATION FROM THE FILM TUBE, AND THE COLLAR WAS INFOLDED. HOWEVER, THE CAUSE FOR THE PARTIAL FEP RING SEPARATION AND COLLAR INFOLDING COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. PER THE GORE® DRYSEAL FLEX INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: BLOOD LOOS, BLEEDING, HEMATOMA.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, DURING THE PROCEDURE USING A 18 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH, A LEAK WAS NOTICED DUE TO A DEFLATION OF THE VALVE. THIS WAS QUICKLY REFILLED WITH THE CORRESPONDING SYRINGE, RODS AND SCREW ON THE STOPPER. THE SAME LOSS OF PRESSURE HAPPENED TWICE MORE. COMPRESSES ARE WEIGHED AND IT IS ESTIMATED THAT THE PATIENT LOST 650 ML OF BLOOD FROM THE LEAK. A NEW GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED TO COMPLETE THE PROCEDURE. NO BLOOD TRANSFUSION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370434 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132630042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown