BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDERX EMBOLIC PROTECTION DEVICE

    MDR report key: 706928 · Received April 27, 2006

    Report

    Report Number
    2183870-2006-00018
    Event Type
    Malfunction
    Date Received
    April 27, 2006
    Date of Event
    March 30, 2006
    Report Date
    March 30, 2006
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN FELT RESISTANCE FROM THE START PARTIALLY THROUGH THE AORTIC ARCH. WHEN CATHETER ON SPIDERX WAS PULLED BACK IT TWISTED ON ITSELT. THE RADIOPAQUE GOLD LOOP IS TWISTED LIKE A FIGURE EIGHT. PHYSICIAN ADVANCED THE CATHETER BACK OVER THE SPIDERX AND PULLED IT OUT. NO PT INJURY OR INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERX EMBOLIC PROTECTION DEVICE NTE NTE EV3 INC. SPDRX-US-060 1396597

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR