BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIEVER24

    MDR report key: 20053156 · Received August 23, 2024

    Report

    Report Number
    3020347218-2024-00038
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 22, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007185
    PMA / PMN Number
    K213402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED BY THE USER FACILITY AND IS 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. THE DEVICE LABELING INCLUDES FOREIGN BODY EMBOLISM AS A POSSIBLE ADVERSE EVENT/COMPLICATION. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON JULY 23, 2024, A PATIENT WITH PULMONARY EMBOLISM (PE) UNDERWENT PE THROMBECTOMY USING INARI DEVICES. DURING THE PROCEDURE, THE TREIVER24 (T24) CATHETER WAS USED TO ASPIRATE CLOT FROM THE PATIENT'S LUNGS. DURING ONE ASPIRATION IN THE LEFT PULMONARY ARTERY, THE DISTAL MARKER BAND DETACHED FROM THE CATHETER BUT REMAINED ON THE GUIDEWIRE. THE PHYSICIAN SUCCESSFULLY ASPIRATED THE MARKER BAND THOUGH THE T24. THE PROCEDURE WAS COMPLETED WITH APPROXIMATELY 95% OF THROMBUS REMOVED. POSTOPERATIVELY, THE PATIENT WAS DOING VERY WELL WITH SIGNIFICANT HEMODYNAMIC IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618349 TRIEVER24 PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 22-101 24030017 00850291007185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown