BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLOTTRIEVER BOLD CATHETER, 6-16MM, 12FR, 80CM

    MDR report key: 23609440 · Received November 20, 2025

    Report

    Report Number
    3020347218-2025-00079
    Event Type
    Death
    Date Received
    November 20, 2025
    Date of Event
    October 22, 2025
    Report Date
    November 20, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007314
    PMA / PMN Number
    K230494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 SHIPPED TO THE FACILITY WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION. 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, WHO CONCLUDED THAT THE PATIENT¿S DEATH WAS LIKELY THE RESULT OF INADVERTENT CLOT EMBOLISM. DISTAL EMBOLIZATION OF BLOOD CLOTS IS IDENTIFIED AS A POSSIBLE ADVERSE EVENT/COMPLICATION IN THE DEVICE LABELING. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 36-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A HISTORY OF PULMONARY EMBOLISM (PE) AND HAD A PREEXISTING FILTER IN HIS INFERIOR VENA CAVA (IVC). THE PATIENT UNDERWENT A PE THROMBECTOMY IN (B)(6) 2025. THE PATIENT HAD BEEN INCARCERATED THE MONTH BEFORE THE DVT THROMBECTOMY, WHICH LEAD TO THE PATIENT DISCONTINUING HIS ELIQUIS PRESCRIPTION. THE PATIENT SUBSEQUENTLY DEVELOPED CLOT IN HIS IVC FILTER THAT EXTENDED TO HIS BILATERAL VEINS BELOW. THE PATIENT IVC FILTER WAS REMOVED VIA THE INTERNAL JUGULAR VEIN (IJ) AND WAS THEN POSITIONED SUPINE FOR THE REMAINING DVT THROMBECTOMY. FOUR PASSES WERE COMPLETED ON THE LEFT AND SIX ON THE RIGHT USING THE CLOTTRIEVER BOLD CATHETER (CT BOLD). AT THE COMPLETION OF THE PROCEDURE, WHILE THE ACCESS SITE WAS BEING CLOSED, THE PATIENT BEGAN TO DECOMPENSATE. A CODE WAS CALLED, AND THE CRITICAL RESPONSE TEAM ATTEMPTED TO RESUSCITATE THE PATIENT FOR EIGHTY MINUTES; HOWEVER, THE PATIENT ULTIMATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2528496 CLOTTRIEVER BOLD CATHETER, 6-16MM, 12FR, 80CM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 42-102 UNKNOWN 00850291007314

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Death