BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 3903331 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04228
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE KINK IN THE BARE WIRE WAS CONFIRMED. THE REPORTED RESISTANCE COULD NOT BE CONFIRMED AS IT WAS BASED ON CASE CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MODERATELY TORTUOUS RIGHT INTERNAL CAROTID. RESISTANCE WAS FELT DURING REMOVAL OF THE DELIVERY CATHETER AFTER PLACEMENT OF THE FILTER. AFTER REMOVAL OF THE DEVICE A BEND/KINK WAS OBSERVED IN THE BARE WIRE. THE DECISION WAS MADE TO REMOVE THE FILTER AND REPLACE THE DEVICE WITH A NEW ONE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379796 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 4040261

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR