BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIEVER24

    MDR report key: 22588264 · Received July 24, 2025

    Report

    Report Number
    3020347218-2025-00047
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 24, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    0081023710096
    PMA / PMN Number
    K213402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 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 DEVICE LABELING INCLUDES THE FOLLOWING WARNING STATEMENTS: "AVOID USING EXCESSIVE FORCE TO ADVANCE OR RETRACT THE FLOWTRIEVER CATHETER OR TRIEVER24 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." MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025 A 73-YEAR-OLD FEMALE PATIENT UNDERWENT PULMONARY EMBOLISM (PE) THROMBECTOMY USING INARI DEVICES. AFTER THE THIRD ASPIRATION USING THE TRIEVER24 CATHETER (T24), THE PHYSICIAN NOTICED THE DEVICE WAS OCCLUDED AND NO CLOT WAS REMOVED. NO KINKS IN THE CATHETER WERE OBSERVED. THE PHYSICIAN ATTEMPTED TO REINSERT THE DILATOR BUT WAS MET WITH SIGNIFICANT RESISTANCE. THE CATHETER LINER HAD SEPARATED AND CAME OUT OF THE DEVICE WHEN THE CATHETER WAS FLUSHED. A NEW DEVICE WAS OPENED, AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188518 TRIEVER24 PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 22-101 25010147 0081023710096

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female FLOWSAVER| FLOWTRIEVER XL CATHETER| INTRI24 INTRODUCER SHEATH| TRIEVER16 CATHETER