BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIX THIN-WALLED SHEATH, 8FR, 65CM

    MDR report key: 25034168 · Received April 29, 2026

    Report

    Report Number
    3020347218-2026-00036
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 29, 2026
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    KRA
    UDI-DI
    00810123710560
    PMA / PMN Number
    K241894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON (B)(6), 2026, A (B)(6) PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE MATRIX SYSTEM OF DEVICES. THE PATIENT WAS PREVIOUSLY PLACED WITH A L SFA STENT. CLOT WAS FOUND WITHIN THE STENT AND THE PHYSICIAN DECIDED TO USE THE MATRIX SYSTEM OF DEVICE AS TREATMENT. THE SHEATH PLACED WITHOUT ANY PROBLEMS NOTED. WHILE HELPING THE TECH PREP THE MT ON THE BACK TABLE, DR. SANDERS ASKED TO FLURO THE LEG. AT THAT POINT THE STAFF NOTED THE MARKER BAND WAS NO LONGER ON THE SHEATH. IT WAS FREE FLOATING IN THE SFA. AFTER MULTIPLE ATTEMPTS TO RETRIEVE IT, THE MARKER FLIPPED INTO THE PROFUNDA. THE ONLY WAY TO REMOVE IT WAS TO CRUSH IT WITH MICRO BRONCHOSCOPY FORCEPS & PULL IT OUT OF THE PATIENT. THE PATIENT WAS PLACED ON EKOS AND TRANSPORTED TO ICU POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429517 ARTIX THIN-WALLED SHEATH, 8FR, 65CM CATHETER, CONTINUOUS FLUSH KRA INARI MEDICAL, INC. 25090168 00810123710560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown