BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 2926185 · Received January 15, 2013

    Report

    Report Number
    3007284313-2013-00003
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    W. L. GORE ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE DRYSEAL SHEATH INSTRUCTIONS FOR USE (IFU), DO NOT ATTEMPT SHEATH ADVANCEMENT OR WITHDRAWAL WITHOUT GUIDEWIRE AND DILATOR IN PLACE. MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PT, INCLUDING DEATH, MAY RESULT. FURTHERMORE, THE IFU STATES: ADEQUATE VESSEL ACCESS IS REQUIRED TO INTRODUCE THE SHEATH INTO THE VASCULATURE. CAREFUL EVAL OF VESSEL SIZE, ANATOMY, TORTUOSITY, AND DISEASE STATE (INCLUDING CALCIFICATION, PLAQUE, AND THROMBUS) IS REQUIRED TO ENSURE SUCCESSFUL SHEATH INTRODUCTION AND SUBSEQUENT WITHDRAWAL. IF VESSEL IS NOT ADEQUATE FOR ACCESS, MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PT, INCLUDING DEATH, MAY RESULT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PHYSICIAN STARTED THE PROCEDURE USING A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT THE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PHYSICIAN ACCESSED THE 18FR DRYSEAL SHEATH (SDV1828/10160837) FROM THE LEFT COMMON FEMORAL ARTERY (CFA) AND ADVANCED FORWARD BUT THE SHEATH WOULD NOT ADVANCE AT THE DISTAL COMMON ILIAC ARTERY (CIA). THE DIAMETER OF LEFT CIA IS 6.0 MM. THE PHYSICIAN CHANGED THE MAIN ROUTE AND TRIED TO INSERT ANOTHER 18FR DRYSEAL SHEATH (SDV1828/10366493) FROM THE RIGHT CFA. THIS WAS NOT POSSIBLE DUE TO THE RIGHT EXTERNAL ILIAC ARTERY (EIA) BEING 5.0 MM IN DIAMETER. THE SDV1828/10160837 FROM THE LEFT SIDE REMAINED IN THE LEFT CFA. THE PHYSICIAN DECIDED TO CHANGE THE SHEATH SIZE DOWN TO A 16FR AND PULLED BOTH SHEATHS BACK FROM THE PT. AT THAT TIME, THE LEFT ILIAC ARTERY WAS RUPTURED. THE PHYSICIAN DECIDED TO CONVERT THE PROCEDURE TO THE Y GRAFTING SURGERY. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22924 GORE DRYSEAL SHEATH DYB / INTRODUCER, CATHETER DYB W. L. GORE ASSOCIATES 10160837

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention