BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDERX EMBOLIC PROTECTION DEVICE

    MDR report key: 714743 · Received May 10, 2006

    Report

    Report Number
    2183870-2006-00020
    Event Type
    Malfunction
    Date Received
    May 10, 2006
    Date of Event
    April 10, 2006
    Report Date
    April 10, 2006
    Manufacturer
    EV3 INC.
    Product Code
    NIE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CAPTURE WIRE BROKE THROUGH 1 TO 2 CM FROM THE DISTAL TIP OF THE DELIVERY CATHETER. THE PHYSICIAN PULLED THE CAPTURE WIRE BACK INTO THE CLEAR SECTION OF THE DELIVERY CATHETER AND USED ANOTHER SPIDERX .060 FILTER WITH THE SAME LOT NUMBER AND WAS SUCCESSFUL. NO PATIENT INJURY OR INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERX EMBOLIC PROTECTION DEVICE NTE NIE EV3 INC. SPDRX-US-060 1396638

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN