BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 24312885 · Received February 11, 2026

    Report

    Report Number
    3007284313-2026-04567
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    January 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

    H6: CODE C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6: CODE B20 -THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION 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 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.

    Additional Manufacturer Narrative · 0

    ADDED G3/G4, H1/H2, H3, H6. ENGINEERING EVALUATION SUMMARY THE DEVICE EVALUATION SHOWED THE FOLLOWING: FRACTURE OF THE SHEATH BODY WAS CONFIRMED. DAMAGE TO THE SHEATH BODY TIP WAS CONFIRMED. FRACTURE OF THE COIL WIRE WAS CONFIRMED. CIRCUMFERENTIAL COMPRESSION OF THE SHEATH BODY WAS CONFIRMED. THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE "D15: CAUSE NOT ESTABLISHED" IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE.

    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 AS AN ACCESSORY. REPORTEDLY, A GORE DRYSEAL SHEATH WAS INTRODUCED VIA A CONTRALATERAL APPROACH (LEFT GROIN ACCESS) WITH THE TIP POSITIONED IN THE RIGHT DISTAL EXTERNAL ILIAC ARTERY THEN A SUPRACORE WIRE WAS PLACED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND CAREFULLY MONITORED TO AVOID CROSSING A FRESH OCCLUSION. A PENUMBRA BOLT 12 CATHETER (PENUMBRA LIGHTNING THROMBECTOMY CATHETER) WAS THEN INSERTED. SOME MILD RESISTANCE WAS FELT DURING THE ADVANCEMENT OF THE BOLT 12 CATHETER. THIS RESISTANCE WAS CONSISTENT WITH PASSING OF A 12FR DEVICE THROUGH A 12FR SHEATH IN A CROSSOVER CONFIGURATION AND WAS NOT EXCESSIVE. FOLLOWING THE RESISTANCE, THE WIRE WAS OBSERVED "JUMPING" ON THE SCREEN. FLUOROSCOPY OF THE AORTIC BIFURCATION REVEALED THE SHEATH HAD TRANSECTED (SNAPPED IN HALF). PHYSICIAN NOTED THAT THIS FAILURE IS UNPRECEDENTED IN THEIR EXPERIENCE AS THEY WOULD HAVE EXPECTED THE SHEATH TO PROLAPSE INTO THE AORTA UNDER TENSION RATHER THAN SNAPPING. THE TIP OF THE PENUMBRA CATHETER REMAINED INTACT AND WAS SUCCESSFULLY USED LATER IN THE PROCEDURE, HOWEVER, THE PROCEDURE WAS TEMPORARILY HALTED TO REMOVE THE DISTAL PORTION OF THE HUB AND VALVE WHILE THE PROXIMAL PORTION WAS REMOVED INTRA-OPERATIVELY (SURGICALLY) DURING THE EMERGENCY RETRIEVAL OF THE SHEATH AND ARTERIAL REPAIR BEFORE RESUMING VIA A NEW ACCESS POINT. PHYSICIAN STATED THAT THE SHEATH COULD NOT BE SIMPLY WITHDRAWN, WHICH LED TO AN EMERGENCY FEMORAL CUTDOWN THAT WAS REQUIRED. AN ENDOGRASPER WAS USED TO RETRIEVE THE DETACHED SHEATH SEGMENTS, AND THE WIRE CONNECTING THE TWO ENDS OF THE FRACTURED SHEATH HAD TO BE CUT TO FACILITATE THE REMOVAL. FOLLOWING THE REMOVAL, THE ARTERY WAS REPAIRED AND THE PROCEDURE WAS CONVERTED TO AN ANTEGRADE PUNCTURE TO COMPLETE THE SUCTION THROMBECTOMY. PROCEDURE WAS THEN COMPLETED. THE AORTIC BIFURCATION WAS SLIGHTLY STEEP, BUT NO SIGNIFICANT CALCIFICATION OR EXTREME TORTUOSITY WAS NOTED AND THE SPECIFIC CAUSE OF THE SHEATH FAILURE IS UNDETERMINED. THERE WAS NO GORE FIELD SALES ASSOCIATE (FSA) PRESENT. 5400-C: ADDITIONAL PROCEDURE OTHER - OTHER/UNKNOWN IS USED TO CAPTURE THE SURGICAL PROCEDURE TO REMOVE PORTION OF THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379805 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132628117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R