BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTHRILL SHEATH, 8FR, 6CM

    MDR report key: 23500024 · Received November 7, 2025

    Report

    Report Number
    3020347218-2025-00077
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    October 10, 2025
    Report Date
    December 2, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007369
    PMA / PMN Number
    K223613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INARI DEVICES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. THE DEVICE IDENTIFIERS WERE NOT PROVIDED, HOWEVER, THE LOT HISTORY RECORDS OF ALL POTENTIAL LOTS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. THE CASE WAS REVIEWED BY INARI STRYKER MEDICAL AFFAIRS TEAM, WHO CONCLUDED THAT THE INARI DEVICES COULD NOT BE RULED OUT AS CONTRIBUTORY TO THE EVENT. THE DEVICE LABELING INCLUDES VESSEL DISSECTION AND VESSEL PERFORATION AS POTENTIAL COMPLICATIONS. MANUFACTURER REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    G1 "REPORTING CONTACT" SHOULD READ "(B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT UPPER EXTREMITY DEEP VEIN THROMBOSIS THROMBECTOMY USING INARI DEVICES. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ANGLING THE INTHRILL SHEATH DUE TO THE PATIENT'S PREEXISTING ARTERIOVENOUS GRAFT. CONTRAST EXTRAVASATION WAS NOTICED ON FLUOROSCOPY AROUND THE ANASTOMOSIS. THE EXTRAVASATION WAS TREATED WITH IMPLANTING A STENT GRAFT. FINAL IMAGING SHOWED GOOD BLOOD FLOW THROUGH THE GRAFT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT UPPER EXTREMITY DEEP VEIN THROMBOSIS THROMBECTOMY USING INARI DEVICES. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ANGLING THE INTHRILL SHEATH DUE TO THE PATIENT'S PREEXISTING ARTERIOVENOUS GRAFT. CONTRAST EXTRAVASATION WAS NOTICED ON FLUOROSCOPY AROUND THE ANASTOMOSIS. THE EXTRAVASATION WAS TREATED WITH IMPLANTING A STENT GRAFT. FINAL IMAGING SHOWED GOOD BLOOD FLOW THROUGH THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923966 INTHRILL SHEATH, 8FR, 6CM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 53-101 UNKNOWN 00850291007369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention