BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLOTTRIEVER CATHETER

    MDR report key: 16421595 · Received February 22, 2023

    Report

    Report Number
    3020347218-2023-00002
    Event Type
    Death
    Date Received
    February 22, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 22, 2023
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007093
    PMA / PMN Number
    K221531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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 THE RESULT OF DISTAL EMBOLIZATION. DISTAL EMBOLIZATION OF BLOOD CLOTS AND CARDIOVASCULAR COLLAPSE ARE LISTED IN THE DEVICE LABELING AS POTENTIAL COMPLICATIONS / ADVERSE EVENTS. MANUFACTURER REFERENCE #:(B)(4).

    Description of Event or Problem · 0

    A 55-YEAR-OLD FEMALE PRESENTED TO THE EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH LEFT LEG ILIOFEMORAL DEEP VEIN THROMBOSIS (DVT). THE PATIENT WAS SCHEDULED FOR A THROMBECTOMY WITH THE INARI CLOTTRIEVER (CT) THROMBECTOMY SYSTEM ON (B)(6) 2023; AT THE TIME OF SURGERY, THE CLOT AGE WAS ESTIMATED AT 5 DAYS. THE CT SHEATH WAS PLACED IN THE PATIENT AND THE CT CATHETER WAS ADVANCED. THE CORING ELEMENT WAS PLACED AT THE TOP OF THE ILIACS STARTING IN THE INTRA VENA CAVA (IVC). THE PHYSICIAN INITIATED THE FIRST PASS AND THE CT CATHETER MOVED 2 CM BEFORE FEELING RESISTANCE. THE CT CATHETER WAS RE-SHEATHED INSIDE OF THE PATIENT AND REMOVED. FOLLOWING THE REMOVAL, THE PHYSICIAN BALLOONED THE ILLIACS AT 3 LOCATIONS WITH A 13 MM X 40 MM BALLOON. THE CT CATHETER WAS INSERTED AGAIN, AND 3 PASSES WERE PERFORMED, BUT THIS EFFORT YIELDED NO CLOT. A PIGTAIL CATHETER WAS THEN INSERTED AND A DIGITAL SUBTRACTION ANGIOGRAPHY WAS PERFORMED WHICH REVEALED THERE WAS NO CLOT PRESENT. AT THIS POINT, THE PATIENT REPORTED DIFFICULTY BREATHING AND HER OXYGENATION (SPO2) DECREASED FROM 100% TO 84%. THE PHYSICIAN ATTEMPTED TO STENT THE ILIACS WHEN THE PATIENT VOMITED AND LOST CONSCIOUSNESS. A CODE WAS INITIATED, AND THE PATIENT WAS REPOSITIONED TO SUPINE TO ENABLE CHEST COMPRESSIONS WHICH CONTINUED FOR OVER 20 MINUTES DURING WHICH TIME A PULSE RETURNED INTERMITTENTLY. ONCE THE PATIENT'S CIRCULATION WAS STABLE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. UNFORTUNATELY, THE PATIENT LATER DIED SOMETIME BETWEEN (B)(6) 2023 AND (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167275 CLOTTRIEVER CATHETER PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 40-102 21120005 00850291007093

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Hospitalization| D| L| R 14 MM X 40 MM BALLOON.| INARI CLOTTREIVER SHEATH 13 FR.| PIGTAIL CATHETER.