BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 23874023 · Received December 22, 2025

    Report

    Report Number
    3020347218-2025-00093
    Event Type
    Death
    Date Received
    December 22, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 22, 2025
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00810123710393
    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, 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'S CHIEF MEDICAL OFFICER, WHO CONCLUDED THAT THE PATIENT¿S DEATH WAS POSSIBLY THE RESULT OF INADVERTENT CLOT EMBOLISM. THE DEVICE LABELING LISTS DISTAL EMBOLIZATION OF BLOOD CLOTS AS A POSSIBLE ADVERSE EVENT/COMPLICATION. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 73-YEAR-OLD MALE PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) THROMBECTOMY USING INARI DEVICE. THE PATIENT HAD ACTIVE METASTATIC CANCER AND PE WITH CONCOMITANT LEFT DVT IN HIS ILIOFEMORAL VEIN. PRE-PROCEDURE, THE PATIENT WAS RECEIVING SUPPLEMENTAL OXYGEN VIA A VENTURI MASK AT 4 L/MIN. THE PATIENT'S PE WAS TREATED FIRST. ACCESS WAS GAINED IN THE RIGHT COMMON FEMORAL VEIN AND NEARLY ALL OF THE PATIENT'S THROMBUS WAS REMOVED USING THE TRIEVER24 (T24) AND TRIEVER20 CURVE (T20C). THE MEDICAL TEAM THEN TREATED THE PATIENT'S DVT. THE PATIENT WAS MOVED TO FROG LEG POSITION AND ACCESS WAS GAINED IN THE LEFT POPLITEAL VEIN. AFTER COMPLETING SEVERAL VENOGRAMS OF THE LOWER LEFT EXTREMITY, A GUIDEWIRE WAS ADVANCED TO THE PATIENT'S SUPERIOR VENA CAVA (SVC) AND A CLOTTRIEVER SHEATH, 13FR (CT SHEATH) WAS INTRODUCED. FOUR PASSES WERE COMPLETED USING THE CLOTTREIVER BOLD CATHETER, FOLLOWED BY TWO ASPIRATIONS OF THE CT SHEATH. A VENOGRAM WAS PERFORMED WHICH REVEALED NEARLY ALL OF THE THROMBUS WAS REMOVED WITH MINIMAL CLOT REMAINING AND A COMPRESSED AREA IN THE PATIENT'S ILIAC VEIN. THE PATIENT THEN SUFFERED FROM AN ARRHYTHMIA WITH NO IMMEDIATE HEMODYNAMIC CHANGES. THE MEDICAL TEAM DECIDED TO PERFORM AN ANGIOPLASTY IN THE COMPRESSED AREA AND IMPLANT A FILTER. WHILE PREPPING THE BALLOON FOR THE ANGIOPLASTY, THE PATIENT'S HEART RATE ELEVATED AND OXYGEN DROPPED. ONCE THE ANGIOPLASTY WAS COMPLETE, THE PATIENT CODED AND CHEST COMPRESSIONS STARTED. IMAGINING WAS TAKEN IN THE PATIENT'S LEFT PULMONARY ARTERY WHICH WAS OBSERVED TO BE OCCLUDED. ATTEMPTS WERE MADE TO REMOVE CLOT USING THE T24 AND T20C, HOWEVER ONLY MINIMAL CLOT WAS REMOVED. A BOLUS OF TPA WAS THEN ADMINISTERED. DESPITE RESUSCITATION EFFORTS, THE PATIENT ULTIMATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703102 CLOTTRIEVER BOLD CATHETER, 6-16MM, 12FR, 80CM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 42-102 UNKNOWN 00810123710393

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death