BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    MDR report key: 17894279 · Received October 9, 2023

    Report

    Report Number
    3007284313-2023-02809
    Event Type
    Malfunction
    Date Received
    October 9, 2023
    Date of Event
    September 7, 2023
    Report Date
    October 9, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DYB
    UDI-DI
    00733132630028
    PMA / PMN Number
    K160254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. PRODUCT EVALUATION SUMMARY: THE DEVICE EVALUATION CONFIRMED THAT THE SHEATH WAS BROKEN ~ 11.5 CM FROM THE LEADING END. THE ROOT CAUSE OF THE BROKEN SHEATH COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. 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) 2023, THE PATIENT UNDERWENT A VENOUS THROMBECTOMY PROCEDURE IN THE POPLITEAL VEIN WITH AN INARI DEVICE UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. REPORTEDLY, DURING THE PROCEDURE THE PHYSICIAN FELT RESISTANCE WITH THE DEVICE IN THE SHEATH, WHEN THEY LOOKED UNDER FLUOROSCOPY, IT LOOKED LIKE THE 16FR DRY SEAL SHEATH WAS SEPARATING. PHYSICIAN WAS ABLE TO REMOVE THE INARI DEVICE AND PUT A BALLOON DOWN OVER AN .035 WIRE THROUGH THE SHEATH IN THE SEPARATED PART, BLEW THE BALLOON UP AND HELD THE TWO PIECES TOGETHER, AFTER WHICH, THE PHYSICIAN WAS ABLE TO REMOVE THE SHEATH FROM THE PATIENT WITH NO PORTION OF THE SHEATH LEFT INSIDE THE BODY. ONCE REMOVED, THEY USED A NEW SHEATH AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632122 GORE® DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER DYB W. L. GORE & ASSOCIATES, INC. 00733132630028

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H