BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 19126277 · Received April 17, 2024

    Report

    Report Number
    3007284313-2024-03176
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    March 21, 2024
    Report Date
    June 27, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132629961
    PMA / PMN Number
    K160254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION FINDINGS CODE C21: INVESTIGATION FINDINGS PENDING COMPLETION OF PRODUCT HISTORY REVIEW AND ENGINEERING EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION FINDINGS CODE C19: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. TYPE OF INVESTIGATION CODE B01: THE DEVICE EVALUATION CONFIRMED APPROXIMATELY 4CM OF THE TRAILING END OF THE SHEATH TUBE BY THE VALVE WAS DAMAGED. THE ROOT CAUSE OF THE SHEATH TUBE DAMAGE COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. H.6. INVESTIGATION CONCLUSIONS CODE D15: 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. ADDED H.6. COMPONENT CODE G04061 ADDED H.6. TYPE OF INVESTIGATION CODED B01, B13, B14 UPDATED H.6. INVESTIGATION FINDINGS FROM C21 TO C07 AND C19 UPDATED H.6. INVESTIGATION CONCLUSIONS FROM D16 TO D15.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT THE SECOND PHASE OF STAGED ENDOVASCULAR TREATMENT FOR THE LEFT COMMON ILIAC ARTERY ANEURYSM AND LEFT INTERNAL ILIAC ARTERY ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). AFTER DEPLOYMENT OF THE STENT GRAFT, NON-GORE BALLOON CATHETER (HYPERFLEX) WAS INSERTED, BUT IT STOPPED ADVANCING PAST THE VALVE OF THE 12FR DSF. WHEN THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT, A WIRE THAT APPEARED TO BE THE COIL OF DSF WAS ENTANGLED WITH THE BALLOON. THE PROCEDURE WAS CONTINUED USING A 14FR DSF. NO ADVERSE EVENT WAS REPORTED. THE PHYSICIAN STATED THE FOLLOWING. I HAVE USED SIMILAR COMBINATIONS BEFORE, BUT THIS IS MY FIRST EXPERIENCE WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926214 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132629961

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female