BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE

    MDR report key: 3231305 · Received July 11, 2013

    Report

    Report Number
    MW5030887
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 11, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS SATISFACTORY PLACEMENT OF AN IVC FILTER, BUT A SMALL METALLIC RING (RADIOPAQUE MARKER) FROM THE TIP OF THE INTRODUCER SHEATH (DILATOR) CAME LOOSE AND WAS RETAINED IN THE PT BETWEEN THE RIGHT CLAVICLE AND THE FIRST RIB. NO FURTHER COMPLICATIONS NOTED. DIAGNOSIS OR REASON FOR USE: TREATMENT FOR DVT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320783 ECLIPSE VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR H302EC500J1S GFUK/022

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR 1 ECLIPSE FILTER| JUGULAR/SUBCLAVIAN DELIVERY DEVICE| 1 10 FR INTRODUCER SHEATH 55 CM LONG WITH DILATOR