BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 3935852 · Received July 15, 2014

    Report

    Report Number
    2024168-2014-04528
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED SEPARATION COULD NOT BE DETERMINED BECAUSE THE BAREWIRE WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MILDLY TORTUOUS AND MILDLY CALCIFIED, COMMON CAROTID ARTERY THE EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE (EPD) WAS BEING ADVANCED WITHOUT REPORTED RESISTANCE FELT WHEN THE BAREWIRE BENT/BROKE AND FELT LOOSE. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414042 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 4020761

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR