BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIX THIN-WALLED SHEATH, 8FR, 65CM

    MDR report key: 23744758 · Received December 8, 2025

    Report

    Report Number
    3020347218-2025-00088
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 8, 2025
    Report Date
    February 20, 2026
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    KRA
    PMA / PMN Number
    K241894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 CONFIRMED THE DISTAL MARKER BAND HAD SEPARATED FROM THE DISTAL END OF THE SHEATH SHAFT. THE SEPARATION LOCATION WAS INSPECTED UNDER MICROSCOPE. THE EXTERIOR SURFACE OF THE SHAFT TUBING END DISPLAYED TUNGSTEN REMNANTS ADHERED TO THE PEBAX SHAFT. THE CROSS-SECTION SURFACE APPEARED SMOOTH AROUND THE FULL CIRCUMFERENCE. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, MANUFACTURING RECORDS COULD NOT BE REVIEWED FOR POTENTIAL DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE MARKER BAND MAY HAVE SEPARATED DUE TO INADEQUATE HEAT BONDING OF THE MARKER BAND; HOWEVER, THE ROOT CAUSE COULD NOT BE CONFIRMED WITHOUT REVIEWING MANUFACTURING RECORDS. MANUFACTURER REFERENCE NUMBER (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 NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 62-YEAR-OLD MALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. WHILE ADVANCING THE ARTIX-THIN-WALLED SHEATH (ARTIX SHEATH), THE RADIOPAQUE MARKER BAND DETACHED FROM THE ARTIX SHEATH. THE PHYSICIAN PROCEEDED WITH THE CASE AND WAS ABLE TO REMOVE ALMOST ALL OF THE PATIENT'S CLOT USING THE ARTIX MECHANICAL THROMBECTOMY DEVICE WITH NO ISSUES. UPON COMPLETION OF THE CASE, THE RADIOPAQUE MARKER BAND WAS REMOVED WITH THE ARTIX FUNNEL CATHETER.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 62-YEAR-OLD MALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. WHILE ADVANCING THE ARTIX-THIN-WALLED SHEATH (ARTIX SHEATH), THE RADIOPAQUE MARKER BAND DETACHED FROM THE ARTIX SHEATH. THE PHYSICIAN PROCEEDED WITH THE CASE AND WAS ABLE TO REMOVE ALMOST ALL OF THE PATIENT'S CLOT USING THE ARTIX MECHANICAL THROMBECTOMY DEVICE WITH NO ISSUES. UPON COMPLETION OF THE CASE, THE RADIOPAQUE MARKER BAND WAS REMOVED WITH THE ARTIX FUNNEL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156580 ARTIX THIN-WALLED SHEATH, 8FR, 65CM CATHETER, CONTINUOUS FLUSH KRA INARI MEDICAL, INC. 30-103 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male