BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 1070696 · Received July 1, 2008

    Report

    Report Number
    2183870-2008-00081
    Event Type
    Other
    Date Received
    July 1, 2008
    Date of Event
    May 26, 2008
    Report Date
    June 4, 2008
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B) (6). AFTER DEPLOYMENT OF THE FILTER, THE PHYSICIAN FOUND THAT THE MARKERBAND WAS SEPARATED FROM THE FILTER. THE PHYSICIAN NOTICED ON THE MONITOR, THE MARKERBAND WAS IN A DIFFERENT POSITION WITHIN THE FILTER. THE MARKERBAND DID NOT EMBOLIZE. THE PHYSICIAN REMOVED THE DEVICE AND USED ANOTHER SPIDERFX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX EMBOLIC PROTECTION DEVICE NTE EV3 INC. SPD2-US-040-320 4219720

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention