BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIEVER24, 24FR, 90CM

    MDR report key: 23647159 · Received November 25, 2025

    Report

    Report Number
    3020347218-2025-00084
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 25, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007185
    PMA / PMN Number
    K213402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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, THE LOT HISTORY RECORDS OF ALL POTENTIAL LOTS SHIPPED TO THE FACILITY WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THE CASE WAS REVIEWED BY INARI STRYKER MEDICAL AFFAIRS, WHO CONCLUDED THAT THE PATIENT¿S INJURY WAS LIKELY THE RESULT OF INADVERTENT CATHETER PERFORATION. THE DEVICE LABELING LISTS PERFORATION OF PULMONARY ARTERIES, AND VESSEL DISSECTION/PERFORATION AS POSSIBLE COMPLICATIONS/ADVERSE EVENTS. MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 75-YEAR-OLD MALE UNDERWENT PULMONARY EMBOLISM (PE) THROMBECTOMY. THE PATIENT HAD SPINE SURGERY TWO DAYS BEFORE THE THROMBECTOMY AND THE PATIENT WAS SCHEDULED TO HAVE A MASS REMOVED THE DAY FOLLOWING THE THROMBECTOMY. AFTER ACCESSING THE RIGHT SIDE, THE MEDICAL TEAM HAD TROUBLE KEEPING THE WIRE PLACEMENT ON THE RIGHT SIDE AS THE PATIENT'S PULMONARY ARTERIES WERE ENLARGED. THE TRIEVER24 CATHETER (T24) FLIPPED WHEN THE DILATOR WAS REMOVED BEFORE THE FIRST RIGHT SIDE ASPIRATIONS. THE CATHETER WAS ADJUSTED TO THE CORRECT PLACEMENT AND THE PROCEDURE CONTINUED. BEFORE THE THIRD ASPIRATION, THE CATHETER WAS ADVANCED WITH THE TIP OF THE GUIDEWIRE OUTSIDE OF THE CATHETER. THE PATIENT'S PRESSURES STARTED TO DROP, AND THE PATIENT WAS ADMINISTERED VASOPRESSORS. THE PATIENT WAS THEN INTUBATED AND A CODE BLUE WAS CALLED. THE PATIENT HAD HIS CHEST CRACKED AND A SMALL PERFORATION WAS NOTED. THE PATIENT WAS EVENTUALLY STABILIZED AND WAS LATER DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2671351 TRIEVER24, 24FR, 90CM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 22-101 UNKNOWN 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| L