BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® DRYSEAL SHEATH

    MDR report key: 4410988 · Received January 13, 2015

    Report

    Report Number
    3007284313-2015-00006
    Event Type
    Injury
    Date Received
    January 13, 2015
    Date of Event
    December 15, 2014
    Report Date
    January 19, 2015
    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

    MANUFACTURING EVALUATION PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE® DRYSEAL SHEATH INSTRUCTION FOR USE (IFU) STATES: VERIFY THE PROPER SIZE INTRODUCER SHEATH IS SELECTED FOR THE DEVICE TO BE INTRODUCED. THE IFU ALSO STATES: ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO BLOOD LOSS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CLINICAL SPECIALIST MADE THE FINAL ENTRY OF THE ORDER INTO NHG'S INTERNAL ORDERING SYSTEM FOR THE GORE® EXCLUDER® AAA ENDOPROSTHESES PLANNED TO BE USED IN THE OPERATION SCHEDULED ON (B)(6) 2014, AT YOUR INSTITUTION. THE CORRECT ORDER FOR A TRUNK-IPSILATERAL LEG WAS (B)(4) (18FR). HOWEVER, (B)(4) (20FR) WAS INADVERTENTLY ENTERED. WITHOUT REALIZING THE ERROR, THE CLINICAL SPECIALIST MADE AN ORDER FOR A GORE® DRYSEAL SHEATH WITH HYDROPHILIC COATING (18FR) AND THE REST OF OTHER DEVICES. ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES.�@A GORE® DRYSEAL SHEATH (DSL1828J/12938929) WAS INSERTED FROM THE PATIENT'S RIGHT FEMORAL ARTERY TO IMPLANT A TRUNK IPSILATERAL LEG ((B)(4) PLANNED). AS PHYSICIAN TRIED TO INSERT THE DELIVERY CATHETER OF THE TRUNK INTO THE SHEATH, IT WAS REALIZED THAT THE DEVICE ON THE TABLE WAS (B)(4) INSTEAD OF (B)(4). THE CORRECT ITEM WAS REQUESTED FOR THE IMMEDIATE DELIVERY, AND THE PATIENT WAS HELD ON THE TABLE WITH THE SHEATH INSERTED FOR ONE HOUR AND HALF UNTIL A (B)(4) WAS DELIVERED. WHILE THE PATIENT WAITED FOR THE DELIVERY ON THE TABLE, A DROP IN THE HEMOGLOBIN LEVEL WAS OBSERVED (11>>7G/DL). THE BLOOD TRANSFUSION WAS PERFORMED TO TREAT ANEMIA. THE (B)(4) AND THE REST OF THE DEVICES WERE IMPLANTED WITHOUT ANY REPORTED ISSUE. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT SIGNIFICANT CALCIFICATION AND SEVERE ADHESION WERE OBSERVED IN THE RIGHT CFA. BUT NO SEVERE BLEEDING WAS REPORTED FOR THE SHEATH INSERTION. IT WAS ALSO REPORTED THAT THERE WAS NO OBVIOUS BLEEDING FROM THE SHEATH WHILE THE PATIENT AWAITED THE ARRIVAL OF THE CORRECT DEVICE. THUS, THE CAUSE OF THE DROP IN THE HEMOGLOBIN LEVEL IS UNKNOWN. THE PHYSICIAN STATED THAT TRANSFUSION BECAME NECESSARY DUE TO THE PROLONGATION OF THE SURGERY (POSSIBLE BLEEDING FROM THE SHEATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28356 GORE® DRYSEAL SHEATH INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES 12938929

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O