BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM GREENFIELD VANA CAVA FILTER

    MDR report key: 16276 · Received February 4, 1994

    Report

    Report Number
    16276
    Event Type
    Injury
    Date Received
    February 4, 1994
    Date of Event
    October 30, 1993
    Report Date
    November 10, 1993
    Manufacturer
    MEDI-TECH
    Product Code
    LWT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A VENA CAVA FILTER INSERTION. THE INITIAL ATTEMPT RESULTED IN PREMATURE DEPLOYMENT OF THE FILTER WITHIN THE INTRODUCER SHEATH. THIS OCCURRED WITHOUT TRIGGERING THE RELEASE MECHANISM FOR THE FILTER. T HE PROCEDURE WAS SALVAGED BY WITHDRAWING THE INTRODUCER WHEATH AND THE CONTAINED FILTER TO A POINT WHERE THE FILTER WAS OUT OF THE SKIN SURFACE. AT THIS POINT THE SHEATH WAS TRANSECTED WITH A KNIFE BLADE AND A GUIDEWIRE WAS INSERTED THROUGH THE REMAINING INTRAVENOUS SHEATH AND WAS SUCCESSFULLY POSITIONED WITHIN THE VENA CAVA. THE PROCEDURE WAS THEN STARTED OVER WITH THE INTRODUCTION OF THE SHEATH AND SUBSEQUENTLY A NEW VENA CAVA FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM GREENFIELD VANA CAVA FILTER VENA CAVA FILTER LWT MEDI-TECH N/A 114873

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention IV NORMAL SALINE AT KOR| 6L O2 PER NASAL CANNULA