BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAUN VENA TECH LGM

    MDR report key: 25960 · Received August 23, 1995

    Report

    Report Number
    25960
    Event Type
    Injury
    Date Received
    August 23, 1995
    Date of Event
    July 11, 1995
    Report Date
    August 15, 1995
    Manufacturer
    B BRAUN MEDICAL, INC.
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A VENA CAVA FILTER WAS INSERTED VIA FEMORAL APPROACH INTO A RESPIRATORY-DEPENDENT PT TO PREVENT BLOOD CLOT FROM MOVING. WHEN PUSHED OUT OF SLEEVE THE FILTER FAILED TO EXPAND/OPEN AND BECAME FREE FLOATING. MANY UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE FILTER VIA FEMORAL AND JUGULAR APPROACHES. A SECOND IVC FILTER WAS INSERTED, VIA THE JUGULAR APPROACH, TO KEEP BOTH THE FIRST FILTER AND THE CLOT FROM MOVING. DURING THE PROCEDURE, PT BECAME HYPOTENSIVE. MICU TEAM AND VASCULAR SURGERY WERE CALLED IMMEDIATELY. THE PT WAS SUCCESSFULLY RESUSCITATED TO SBP 100 AND RETURNED TO MICU IN GUARDED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN VENA TECH LGM Implant 30 D/U VENA CAVA FILTER DTK B BRAUN MEDICAL, INC. 30 D/U

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention RESPIRATOR