BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENA TECH VENA CAVA FILTER

    MDR report key: 166030 · Received April 30, 1998

    Report

    Report Number
    1421378-1998-90001
    Event Type
    Malfunction
    Date Received
    April 30, 1998
    Date of Event
    April 10, 1998
    Report Date
    April 23, 1998
    Manufacturer
    B. BRAUN VENA-TECH
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED A RIGHT SIDED FEMORAL APPROACH FOR VENA CAVA FILTER PLACEMENT. AS HE ADVANCED THE FILTER THROUGH THE SHEATH, A HOOK ON THE LEG OF THE FILTER ENGAGED THE INSIDE OF THE SHEATH PREVENTING IT FROM BEING ADVANCED FURTHER. THE SHEATH AND FILTER WERE REMOVED WITHOUT INCIDENT. A SECOND VENA-TECH-LGM VENA CAVA FILTER WAS SUCCESSFULLY PLACED. THE PT REMAINS STABLE AND HAS SUFFERED NO ADVERSE EFFECTS FROM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENA TECH VENA CAVA FILTER Implant VENA CAVA FILTER DTK B. BRAUN VENA-TECH 30DU 28198B03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other