BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 15027851 · Received July 14, 2022

    Report

    Report Number
    MW5110877
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    July 6, 2022
    Report Date
    July 12, 2022
    Manufacturer
    EV3, INC.
    Product Code
    NTE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPIDER WIRE WAS PROPERLY PREPARED PRIOR TO ATTEMPTING TO INTRODUCE THE DEVICE INTO THE CATHETER. THE DEVICE (SPIDER WIRE) DID NOT FEED INTO THE CATHETER AND DID NOT ENTER THE PATIENT'S BODY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057592 SPIDERFX EMBOLIC PROTECTION DEVICE TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE EV3, INC. B318888

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female