BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2955787 · Received February 11, 2013

    Report

    Report Number
    2024168-2013-00797
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PREPARING THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM, A 300 LENGTH BAREWIRE WAS PULLED THROUGH THE NAV 6 FROM THE DISTAL END INSTEAD OF THE GUIDE WIRE EXIT PORT AND THE DELIVERY CATHETER SHAFT BROKE. THERE WAS NO FORCE APPLIED TO THE NAV 6 OR THE GUIDE WIRE PRIOR TO THE BREAKAGE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER NAV 6 EMBOLIC PROTECTION SYSTEM WAS PREPPED AND USED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59756 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 2060861

    Patients

    Seq Age Sex Outcome Treatment
    1