BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYB/INTRODUCER, CATHETER

    MDR report key: 2671216 · Received March 29, 2010

    Report

    Report Number
    2017233-2009-90002
    Event Type
    Injury
    Date Received
    March 29, 2010
    Date of Event
    August 6, 2009
    Report Date
    August 18, 2009
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K013282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT WAS TREATED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE TRUNK IPSILATERAL LEG COMPONENT WAS DEPLOYED ON THE RIGHT SIDE WITHOUT INCIDENT. WHEN INTRODUCING THE 18 FRENCH GORE INTRODUCER SHEATH, THE SHEATH CAUGHT ON TO THE IPSILATERAL LIMB OF THE TRUNK IPSILATERAL LEG COMPONENT AND PUSHED THE TRUNK IPSILATERAL LEG COMPONENT 5-6 CM PROXIMAL TO THE LOWEST RENAL ARTERY. THE PHYSICIAN OPTED TO GET A WIRE UP AND OVER INSIDE THE TRUNK IPSILATERAL LEG COMPONENT AND SNARE THE DEVICE BACK DOWN BELOW THE LOWEST RENAL ARTERY. THE PHYSICIAN CONTINUED THE PROCEDURE WITHOUT INCIDENT. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYB/INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES WLG345 02746852

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O