BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 1241249 · Received November 7, 2008

    Report

    Report Number
    2183870-2008-00168
    Event Type
    Injury
    Date Received
    November 7, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 4.0 SPIDERFX WAS LOADED ON THE 0.014 WIRE. DELIVERY CATHETER TRACKED THROUGH THE TORTUOUS ANATOMY. THE SPIDER COULD ONLY TRACK PARTIALLY THROUGH THE DELIVERY CATHETER. AS THE PHYSICIAN STARTED TO PULL BACK ON THE DELIVERY CATHETER TO EXPOSE THE SPIDER FILTER, HE HEARD A SNAP. HE COULD PULL BACK THE DELIVERY CATHETER, BUT THE DISTAL MARKER WAS NOT MOVING. THE SPIDERFX WAS IN THE DISTAL HALF OF THE DELIVERY CATHETER. THE PHYSICIAN THEN DECIDED TO PULL THE WIRE AND THE SPIDERFX AND CATHETER CAME OUT. EVERYTHING WAS RECOVERED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX EMBOLIC PROTECTION DEVICE NTE EV3 INC. SPD2-US-040-320 6568270

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention