BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 23164066 · Received September 28, 2025

    Report

    Report Number
    3007284313-2025-04270
    Event Type
    Malfunction
    Date Received
    September 28, 2025
    Date of Event
    August 20, 2025
    Report Date
    November 24, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    PMA / PMN Number
    K160254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9: UPDATE DATE DEVICE RETURNED TO MANUFACTURER. H6: CODE C19 - THE PRODUCT MET CREGANNA MEDICAL SPECIFICATIONS AND PROCEDURES. CODE D15 - THE FINDINGS FROM THE EVALUATION ARE CONSISTENT WITH THE REPORTED VALVE RUPTURE, AS LEAKAGE WAS OBSERVED FROM THE VALVE; HOWEVER, THE CAUSE FOR THE LEAKAGE COULD NOT BE DETERMINED. ENGINEERING EVALUATION DID OBSERVE DENSIFICATION ON THE FILM TUBE AND INFOLDING OF THE FILM TUBE COLLAR, BUT THERE WAS NO DAMAGE NOR PRODUCT ANOMALIES OBSERVED WHICH EXPLAIN THE REPORTED LEAKAGE. THE CAUSE FOR THE REPORTED RUPTURED DRYSEAL SHEATH VALVE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H6: CODE C21 - THE DEVICE WILL BE RETURNED AND WILL BE EVALUATED BY GORE. 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 NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT A PATIENT WAS TO BE USED WITH A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DRYSEAL DEVICE) TO DURING AN EVAR PROCEDURE. DURING THE PROCESS OF INSERTING AORTIC ENDOPROSTHESIS, THE DRYSEAL DEVICE VALVE RUPTURED. THEREFORE, THE ENDOPROSTHESIS WAS WITHDRAWN AND SHEATH WAS REMOVED FROM PATIENT. THE SAME ENDOPROSTHESIS AND ANOTHER NEW DRYSEAL DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. PATIENT TOLERATED PROCEDURE WITHOUT ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410690 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female