BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENA TECH VENA CAVA FILTER

    MDR report key: 167535 · Received May 12, 1998

    Report

    Report Number
    1421378-1998-90002
    Event Type
    Malfunction
    Date Received
    May 12, 1998
    Date of Event
    May 1, 1998
    Report Date
    May 12, 1998
    Manufacturer
    B. BRAUN VENA-TECH
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN INSERTED A VENA TECH-LGM VENA CAVA FILTER FROM THE RIGHT INTERNAL JUGUALR APPROACH AND INADVERTENTLY PLACED THE FILTER IN A GONADAL OR STEEP LUMBAR VEIN. A SECOND VENA TECH-LGM VENA CAVA FILTER WAS PROPERLY DEPLOYED WITHIN THE INFERIOR VENA CAVA WITHOUT DIFFICULTY. THE PATIENT 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 64897I01

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other