BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIX THIN-WALLED SHEATH

    MDR report key: 23426706 · Received October 30, 2025

    Report

    Report Number
    3020347218-2025-00075
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 12, 2025
    Report Date
    October 30, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    KRA
    PMA / PMN Number
    K241894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) WAS RETURNED TO THE MANUFACTURER AND EVALUATED. VISUAL INSPECTION OF THE DEVICE REVEALED THE SHEATH SHAFT SEPARATED AT THE PROXIMAL MARKER. THE SHEATH SHAFT SEPARATION EXPOSED THE INNER COIL AND DELAMINATION PROXIMAL TO THE BREAK WAS OBSERVED. 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. CORRECTIVE ACTION WAS OPENED TO FURTHER INVESTIGATE AND DETERMINE POTENTIAL ROOT CAUSE. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 71-YEAR-OLD MALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. UPON REMOVING THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH), THE SHEATH SHAFT BEGAN TO UNRAVEL. THE ARTIX SHEATH WAS REMOVED COMPLETELY, AND A NEW ARTIX SHEATH WAS USED TO COMPLETE THE CASE WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619157 ARTIX THIN-WALLED SHEATH CATHETER, CONTINUOUS FLUSH KRA INARI MEDICAL, INC. 30-104 25040175

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male ARTIX AX ASPIRATION CATHETER.| ARTIX MECHANICAL THROMBECTOMY CATHETER.