BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 3891394 · Received June 24, 2014

    Report

    Report Number
    2024168-2014-04030
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN INTERVENTIONAL LOWER EXTREMITY PROCEDURE, THE FILTER OF A NAV6 EMBOLIC PROTECTION DEVICE (EPD) SEPARATED AFTER IT WAS LOADED INTO THE DELIVERY CATHETER. THE SEPARATION OCCURRED BEFORE THE DEVICE WAS INSERTED INTO THE PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED WITHOUT USING AN EPD. IT WAS REPORTED THAT THERE WAS A TWO MINUTE DELAY IN THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368204 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1