BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOTTRIEVER XL CATHETER, 16FR, 105CM

    MDR report key: 24956008 · Received April 22, 2026

    Report

    Report Number
    3020347218-2026-00034
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 22, 2026
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    PMA / PMN Number
    K242557
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. THE LOT 25060152 AND 26010140 WERE PROVIDED VIA SHIPPING RECORDS. ALL POSSIBLE LOTS FOR THIS COMPLAINT WERE REVIEWED. 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 DEVICE WAS NOT RETURNED THUS THE FAILURE MODE WAS NOT CONFIRMED THROUGH FAILURE ANALYSIS. THIS ADVERSE EVENT WAS REVIEWED BY STRYKER PERPIHERAL VASCULAR MED AFFAIRS AND THE AVAILABLE INFORMATION REASONABLY SUGGESTS THE STRYKER PV DEVICE MAY HAVE CONTRIBUTED TO THE PATIENT'S CLINICAL DETERIORATION THROUGH DISTAL CLOT EMBOLIZATION.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE CLOTTRIEVER SYSTEM OF DEVICES. THE PATIENT PRESENTED WITH EXTENSIVE ILIAC AND INFRARENAL INFERIOR VENA CAVA (IVC) THROMBUS. FOLLOWING THE FIRST PASS, THE PATIENT EXPERIENCED ACUTE CLINICAL DETERIORATION, INCLUDING A DROP IN OXYGEN SATURATION AND INCREASE IN HEART RATE AND MEDICAL INTERVENTION WAS REQUIRED. THROMBECTOMY PROCEDURE WAS NOT COMPLETED, AND NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328000 CLOTTRIEVER XL CATHETER, 16FR, 105CM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 41-102 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening