BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 1200185 · Received September 26, 2008

    Report

    Report Number
    2183870-2008-00125
    Event Type
    Other
    Date Received
    September 26, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SPIDERFX ADVANCED OVER THE WIRE SUCCESSFULLY, AND THEN REMOVED. THE SPIDERFX WAS THEN ADVANCED TO THE TARGET AREA AND WHEN THE PHYSICIAN PULLED THE CATHETER, THE FILTER DID NOT DEPLOY. AFTER REMOVING THE CATHETER, IT WAS FOUND THAT THE CATHETER WAS BROKEN INTO TWO PIECES. THE PHYSICIAN RETRIEVED THE CATHETER SEGMENT BY PULLING THE SPIDERFX WIRE OUT GENTLY WITH THE CATHETER SEGMENT TOGETHER. ALL PIECES WERE REMOVED. THE PHYSICIAN THEN COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX EMBOLIC PROTECTION DEVICE NTE EV3 INC. SPD2-US-070-320 5989908

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other