BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2160472 · Received July 13, 2011

    Report

    Report Number
    2024168-2011-04950
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. POTENTIAL FACTORS THAT COULD CAUSE DAMAGE OR TEARS TO THE FILTRATION ELEMENT MEMBRANE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, INTERACTION WITH SEVERE CALCIFICATION, INTERACTIONS WITH ASSOCIATED DEVICES OR INTERACTION WITH A STENT DURING REMOVAL. IN THIS CASE, THE EMBOSHIELD NAV 6 WAS NOT RETURNED FOR ANALYSIS, WHICH WOULD HAVE AIDED IN DETERMINING A POTENTIAL CAUSE FOR THE DAMAGE. THE LOT HISTORY RECORD 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. WITHOUT HAVING THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. TO ENSURE THIS TYPE OF DAMAGE IS NOT MANUFACTURING RELATED, AS PART OF THE MANUFACTURING QUALITY PROCESS, ALL EMBOLIC PROTECTION DEVICES ARE 100% VISUALLY INSPECTED FOR DAMAGE. IN ADDITION, A SAMPLING OF UNITS IS VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED.

    Description of Event or Problem · 1

    REPORTEDLY POST INTERVENTION OF A DISTAL POPLITEAL WITH THE NAV6 EMBOSHIELD WHICH IS CONSIDERED OFF LABEL USE, WHEN THE FILTER BASKET WAS RETRIEVED OUTSIDE OF THE PATIENT, IT WAS NOTED THAT THERE WAS A BREACH IN THE MEMBRANE OF THE FILTER BASKET. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE PATIENT EFFECTS DURING THE PROCEDURE. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS NOT REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1