BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTIX 8F THIN WALLED SHEATH

    MDR report key: 23693347 · Received December 2, 2025

    Report

    Report Number
    MW5179694
    Event Type
    Other
    Date Received
    December 2, 2025
    Report Date
    November 26, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    KRA
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ATTEMPTED THROMBECTOMY WITH INARI ARTERIAL THROMBECTOMY SYSTEM. FIRST ATTEMPT WAS SUCCESSFUL, HOWEVER RESIDUAL CLOT REMAINED. DURING SECOND ATTEMPT, THE DISTAL RADIOPAQUE MARKER ON THE INARI SHEATH DETACHED FROM SHEATH FOR UNKNOWN REASON. IT APPEARED TO BE IMBEDDED IN THE RESIDUAL CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864543 ARTIX 8F THIN WALLED SHEATH CATHETER, CONTINUOUS FLUSH KRA INARI MEDICAL, INC. 30-103 25060024

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male