BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 16595576 · Received March 22, 2023

    Report

    Report Number
    3007284313-2023-02401
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    February 20, 2023
    Report Date
    May 10, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630950
    PMA / PMN Number
    K160254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.9. DEVICE RETURNED TO MANUFACTURER & DATE: UPDATED. H.6. INVESTIGATION FINDINGS FOR TESTING OF ACTUAL/SUSPECTED DEVICE: CODE C070601 - THE DEVICE WAS RETURNED TO GORE FOR EVALUATION. THE ENGINEERING EVALUATION DETERMINED THE FOLLOWING: THE DEVICE EVALUATION CONFIRMED THAT APPROXIMATELY 3MM OF THE SHEATH LEADING END HAD BEEN DAMAGED. THE DILATOR WAS REMOVED FOR VISUAL INSPECTION AND IT WAS FOUND THAT THE SHEATH LEADING END HAD THE APPEARANCE OF COMPRESSION DAMAGE. THIS COULD BE INTERPRETED AS A TEAR IN THE WORKING ENVIRONMENT, BUT ONLY DEFORMATION WAS NOTED. THE ROOT CAUSE OF THE SHEATH DAMAGE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. H.6. INVESTIGATION FINDINGS FOR TESTING OF ACTUAL/SUSPECTED DEVICE: CODE C21 UPDATED TO CODE C070601. H.6. INVESTIGATION CONCLUSIONS: CODE D16 UPDATED TO CODE D15

    Additional Manufacturer Narrative · 0

    PATIENT WEIGHT: ASKED BUT UNAVAILABLE OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: ASKED BUT UNAVAILABLE CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ASKED BUT UNAVAILABLE INVESTIGATION FINDINGS: CODE C19 - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. 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

    ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT A 24FR. GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) WAS BEING USED AS AN ACCESSORY ON THE PATIENT'S RIGHT SIDE. REPORTEDLY, DURING ADVANCEMENT, THE SHEATH HIT A LEDGE OF CALCIUM. THE PHYSICIAN KEPT PUSHING AGAINST THE LEDGE OF CALCIUM AND THE PROXIMAL END OF THE DSF TORE. IT REPORTEDLY APPEARED THAT THE SHEATH HAD BEEN SHEARED AT THE TRANSITION POINT AND THE DILATOR WAS STILL FULLY INTACT. IT WAS REPORTED THAT THE PHYSICIAN STOPPED PUSHING, THE SHEATH WAS SUCCESSFULLY REMOVED, AND NO DEVICES WERE ADVANCED THROUGH THE 24FR. INTRODUCER SHEATH. A 22 FR. DSF WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, DURING ACCESS SITE CLOSURE, THE PHYSICIAN WAS NOT ABLE TO ACHIEVE HEMOSTASIS WITH THE ABBOTT PERCLOSE¿ CLOSURE DEVICES. CUT DOWN WAS PERFORMED AT THE PATIENT'S RIGHT ACCESS SITE WHICH WAS SUSPECTED TO BE RELATED TO THE LARGE SIZE OF THE 24 FR. SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555508 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. DSF2433 00733132630950

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| O