BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6

    MDR report key: 24675607 · Received March 24, 2026

    Report

    Report Number
    2024168-2026-01198
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NTE
    UDI-DI
    08717648137754
    PMA / PMN Number
    K191173
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION, EXCHANGING THE PROVIDED BAREWIRE FILTER DELIVERY WIRE FOR THE 0.014¿ VIPERWIRE PREVENTED THE ABILITY TO RETRIEVE THE FILTER, CAUSING THE FILTER TO COME OFF THE WIRE DURING RETRIEVAL RESULTING IN UNEXPECTED MEDICAL INTERVENTION TO RETRIEVE THE FILTER WITH A SNARE DEVICE. THE BAREWIRE FILTER DELIVERY WIRE CONTAINS AN 0.019¿ STEP WHICH PREVENTS THE FILTRATION ELEMENT FROM COMING OFF THE DISTAL END OF THE WIRE DURING FILTER RETRIEVAL. THE EMBOSHIELD NAV6 INSTRUCTION FOR USE (EIFU)¿ GENERAL WARNINGS) STATES: ¿THE EMBOSHIELD NAV6 DEVICE CAN ONLY BE USED WITH THE BAREWIRE FILTER DELIVERY WIRE. USE OF THE DEVICE WITH ANY GUIDE WIRE OTHER THAN THE BAREWIRE FILTER DELIVERY WIRE WILL LEAD TO LOSS OF THE FILTRATION ELEMENT DURING THE PROCEDURE OR AN INABILITY TO RETRIEVE THE FILTRATION ELEMENT¿. THE BAREWIRE FILTER DELIVERY WIRE CONTAINS AN 0.019¿ STEP WHICH PREVENTS THE FILTRATION ELEMENT FROM COMING OFF THE WIRE DURING FILTER RETRIEVAL. AN IN-SERVICE HAS BEEN REQUESTED TO ADDRESS THE IFU VIOLATION AND HOW IT CONTRIBUTED TO THE DIFFICULTIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. H6 MEDICAL DEVICE PROBLEM CODE: 2017 - GUIDE WIRE / FDW SELECTION INCORRECT

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). PRIOR TO USE THE BAREWIRE OF THE LARGE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS EXCHANGED FOR A .014 VIPER GUIDE WIRE (GW). AFTER USE IN THE PROCEDURE, WHEN REMOVING THE FILTER, THE FILTER CAME OFF THE VIPER GW. THEREFORE, A SNARE WAS USED TO RETRIEVE THE FILTER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732824 EMBOSHIELD NAV6 TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE ABBOTT VASCULAR INC. 22438-19 5071861 08717648137754

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention