BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIX THIN-WALLED SHEATH

    MDR report key: 23194480 · Received October 1, 2025

    Report

    Report Number
    3020347218-2025-00063
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 3, 2025
    Report Date
    December 18, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    KRA
    PMA / PMN Number
    K241894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE CONFIRMED THE DISTAL MARKER BAND HAD SEPARATED FROM THE END OF THE SHEATH SHAFT. THE DEVICE WAS OBSERVED UNDER MICROSCOPIC IMAGING AND A CLEAN BREAK OF MATERIAL WAS OBSERVED FROM THE PEBAX TO THE TUNGSTEN MARKER BAND TRANSITION WITH INADEQUATE ADHESIVE OBSERVED. THE MARKER BAND LIKELY SEPARATED DUE TO INADEQUATE HEAT BONDING OF THE MARKER BAND TO THE PEBAX SHAFT. THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. ADDITIONALLY, A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND NO SIMILAR ISSUES HAVE BEEN REPORTED AGAINST THIS LOT NUMBER. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 72-YEAR-OLD MALE UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 14 DAYS. THE PATIENT HAD PREEXISTING STENTS IN THE LEFT COMMON AND LEFT POPLITEAL ARTERIES. THE PATIENT'S RIGHT GROIN WAS ACCESSED AND THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) WAS ADVANCED TO THE LEFT COMMON ILIAC STENT TO THE DISTAL SUPERFICIAL FEMORAL ARTERY. THE DILATOR WAS REMOVED AND THE FUNNEL CATHETER WAS INSERTED. WHILE EXPOSING THE FUNNEL CATHETER, THE MARKER BAND FROM THE ARTIX SHEATH WAS OBSERVED MOVING. THE FUNNEL WAS DEPLOYED AND THE GUIDEWIRE WAS EXCHANGED AND THE PHYSICIAN WIRED AROUND/PAST THE MARKER. THE ARTIX MECHANICAL THROMBECTOMY CATHETER (MT) WAS DEPLOYED AND THE MARKER BAND WAS EXTRACTED ALONG WITH SOME CLOT. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES AND THE PATIENT HAD FULL FLOW RESTORED POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105947 ARTIX THIN-WALLED SHEATH CATHETER, CONTINUOUS FLUSH KRA INARI MEDICAL, INC. 30-104 25050117

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male ARTIX MECHANICAL THROMBECTOMY CATHETER