BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIX THIN-WALLED SHEATH, 8FR, 90CM

    MDR report key: 23648552 · Received November 25, 2025

    Report

    Report Number
    3020347218-2025-00085
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    October 28, 2025
    Report Date
    December 19, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    KRA
    UDI-DI
    00810123710577
    PMA / PMN Number
    K241894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) WAS RETURNED TO THE MANUFACTURER AND INVESTIGATED. VISUAL INSPECTION CONFIRMED THE ARTIX SHEATH HAD FIVE AREAS WHERE THE SHEATH SHAFT HAD SEPARATED AND THE COIL WAS EXPOSED. 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 ARTIX SHEATH MOST LIKELY SEPARATED DUE TO EXCESSIVE FORCE USED TO ADVANCE/RETRACT THE DEVICE AGAINST RESISTANCE. THE DEVICE LABELING INCLUDES THE FOLLOWING WARNING: "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." CORRECTION TO INITIAL REPORT (3020347218-2025-00085), SECTION B5: INITIAL REPORT STATED "ALL DEVICES WERE REMOVED THROUGH THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH), HOWEVER UPON REMOVAL OF THE DILATOR, THE DILATOR WOULD NOT RETRACT. " B5 SHOULD READ "ALL DEVICES WERE REMOVED THROUGH THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH), AND THE ARTIX SHEATH DILATOR WAS REINSERTED WHILE REMOVING THE ARTIX SHEATH. UPON REMOVING THE ARTIX SHEATH, RESISTANCE WAS FELT. " 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 59-YEAR-OLD FEMALE UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 14 DAYS. DURING THE PROCEDURE, CLOT WAS REMOVED ON THE RIGHT AFTER SEVEN PASSES WITH THE ARTIX MECHANICAL THROMBECTOMY DEVICE (MT6) AND A STENT WAS PLACED IN THE RIGHT ILIAC ARTERY. WHILE COMPLETING FLUOROSCOPY, SOME CLOT WAS EMBOLIZED AS A RESULT OF BALLOONING. ONE MORE PASS USING THE MT6 REMOVED THE EMBOLIZED CLOT. IMAGING CONFIRMED NORMAL FINDINGS. ALL DEVICES WERE REMOVED THROUGH THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH), AND THE ARTIX SHEATH DILATOR WAS REINSERTED WHILE REMOVING THE ARTIX SHEATH. UPON REMOVING THE ARTIX SHEATH, RESISTANCE WAS FELT. THE PHYSICIAN PULLED THE ARTIX SHEATH AND THE SHEATH CAME APART IN A SECTION. THE PHYSICIAN MOVED CLOSER TO THE ACCESS AND PULLED AGAIN, WHICH RESULTED IN ANOTHER TEAR IN THE SHEATH. THE PHYSICIAN USED HEMOSTATS AND INCREASED THE DILATION OF THE SITE, AND EVERYTHING WAS FULLY REMOVED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 59-YEAR-OLD FEMALE UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 14 DAYS. DURING THE PROCEDURE, CLOT WAS REMOVED ON THE RIGHT AFTER SEVEN PASSES WITH THE THE ARTIX MECHANICAL THROMBECTOMY DEVICE (MT6) AND A STENT WAS PLACED IN THE RIGHT ILIAC ARTERY. WHILE COMPLETING FLUOROSCOPY, SOME CLOT WAS EMBOLIZED AS A RESULT OF BALLOONING. ONE MORE PASS USING THE MT6 REMOVED THE EMBOLIZED CLOT. IMAGING CONFIRMED NORMAL FINDINGS. ALL DEVICES WERE REMOVED THROUGH THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH), HOWEVER UPON REMOVAL OF THE DILATOR, THE DILATOR WOULD NOT RETRACT. THE PHYSICIAN PULLED THE ARTIX SHEATH AND THE SHEATH CAME APART IN A SECTION. THE PHYSICIAN MOVED CLOSER TO THE ACCESS AND PULLED AGAIN, WHICH RESULTED IN ANOTHER TEAR IN THE SHEATH. THE PHYSICIAN USED HEMOSTATS AND INCREASED THE DILATION OF THE SITE, AND EVERYTHING WAS FULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137298 ARTIX THIN-WALLED SHEATH, 8FR, 90CM CATHETER, CONTINUOUS FLUSH KRA INARI MEDICAL, INC. 30-104 25050074R 00810123710577

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female