BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIX THIN-WALLED SHEATH

    MDR report key: 23194750 · Received October 1, 2025

    Report

    Report Number
    3020347218-2025-00064
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 2, 2025
    Report Date
    December 19, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    KRA
    PMA / PMN Number
    K241894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 REVEALED A BREAK OCCURRED APPROXIMATELY 15CM DISTAL TO THE STRAIN RELIEF OF THE SHEATH. 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. THE SHEATH SHAFT DAMAGE WAS LIKELY CAUSED BY TORTUOUS ANATOMY AND UNDERLYING DISEASE THAT CREATED WORST CASE CONDITIONS FOR SHEATH USAGE AND WAS EXACERBATED BY RETRACTING OVER AN UNSUPPORTIVE WIRE AND NOT INSERTING A DILATOR WHEN RESISTANCE WAS INITIALLY FELT. THE DEVICE LABELING INCLUDES THE FOLLOWING WARNING STATEMENTS: "AVOID USING EXCESSIVE FORCE TO ADVANCE THE ARTIX SHEATH AGAINST RESISTANCE. IF EXCESSIVE RESISTANCE OCCURS, RETRACT, AND REMOVE THE DEVICE. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE DEVICE OR VESSEL PERFORATION." "NEVER ADVANCE OR TORQUE THE ARTIX SHEATH AGAINST RESISTANCE WITHOUT CAREFUL ASSESSMENT OF CAUSE OF RESISTANCE USING FLUOROSCOPY." "ADEQUATE VESSEL ACCESS IS REQUIRED TO INTRODUCE THE ARTIX SHEATH INTO THE VASCULATURE. CAREFUL EVALUATION OF VESSEL SIZE, ANATOMY, TORTUOSITY, AND DISEASE STATE (INCLUDING PLAQUE, CALCIFICATIONS, AND THROMBUS) IS REQUIRED TO ENSURE SUCCESSFUL SHEATH INTRODUCTION AND SUBSEQUENT WITHDRAWAL. IF VESSEL IS NOT ADEQUATE FOR ACCESS, MAJOR BLEEDING, VESSEL DAMAGE, OR SERIOUS INJURY TO THE PATIENT, INCLUDING DEATH, MAY RESULT." THE MANUFACTURER'S 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. THE MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A MALE PATENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT TWO DAYS. WHILE REMOVING THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) DURING THE THROMBECTOMY, RESISTANCE WAS MET WHILE PULLING THE DEVICE OVER A BIFURCATION AND THE PHYSICIAN PULLED THE SHEATH WITH MORE FORCE TO REMOVE THE DEVICE. THE ARTIX SHEATH SEPARATED, AND THE PORTION REMAINING IN THE PATIENT WAS ABLE TO BE REMOVED COMPLETELY WITHOUT INJURY USING THE GUIDEWIRE. THE CASE WAS CONCLUDED WITHOUT FURTHER ISSUES AND THE PATIENT HAD FULL FLOW RESORTED POST-THROMBECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2622061 ARTIX THIN-WALLED SHEATH CATHETER, CONTINUOUS FLUSH KRA INARI MEDICAL, INC. 30-103 25050116R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ARTIX MECHANICAL THROMBECTOMY CATHETER