BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 24611887 · Received March 16, 2026

    Report

    Report Number
    3007284313-2026-04628
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 17, 2026
    Report Date
    April 14, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132628117
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED G3/G4, H1/H2, H3, H6. H6: CODE C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ENGINEERING EVALUATION SUMMARY: THE DEVICE EVALUATION SHOWED THE FOLLOWING: FRACTURE OF THE SHEATH BODY WAS CONFIRMED. FRACTURE OF THE COIL WIRE WAS CONFIRMED. SHEATH BODY KINKS WERE CONFIRMED AT FIVE (5) LOCATIONS ALONG THE LEADING PORTION OF THE FRACTURED ITEM. CIRCUMFERENTIAL COMPRESSION OF THE SHEATH BODY WAS CONFIRMED AT THREE (3) LOCATIONS ALONG THE LEADING PORTION OF THE FRACTURED ITEM.

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ACUTE LIMB ISCHEMIA UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) AS AN ACCESSORY. THE SHEATH WAS INSERTED VIS DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) THEN ADVANCED UP AND OVER THE TIGHT AORTIC BIFURCATION. DURING ADVANCEMENT, SOME RESISTANCE FELT BUT SHEATH ADVANCED APPROPRIATELY. THE PENUMBRA LIGHTNINGBOLT DEVICE WAS ADVANCED WHEN THE SHEATH TRANSECTED IN TWO. A SFA CUTDOWN WAS REQUIRED TO CUT THE WIRE CONNECTING THE TWO PARTS OF THE SHEATH AND FACILITATE REMOVAL. PHYSICIAN STATES ITS POSSIBLY DUE THE LACK OF A TAPERED INTRODUCER FOR THE THROMBECTOMY DEVICE, COMBINED WITH THE 4.0MM INNER DIAMETER OF THE DSF AND THE 4.04MM OD OF THE LIGHTNING BOLT 12 IN THE SETTING OF A LIKELY COMPRESSED/FOLDED DSF LUMEN (OVER THE TIGHT AORTIC BIFURCATION) AND THE STIFFNESS OF THE THROMBECTOMY DEVICE ONCE FORCED INTO A SMALL LUMEN THAT CAUSED THE SHEATH TO TRANSECT IN TWO. THERE WAS NO GORE FIELD SALES ASSOCIATE (FSA) PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147635 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132628117

    Patients

    Seq Age Sex Outcome Treatment
    1