BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOTTRIEVER BOLD CATHETER

    MDR report key: 19933725 · Received August 7, 2024

    Report

    Report Number
    3020347218-2024-00036
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 7, 2024
    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, 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 DETERIORATION WAS LIKELY THE RESULT OF DISTAL CLOT EMBOLISM. MANUFACTURER REFERENCE #: (B)(4). DISTAL EMBOLIZATION OF BLOOD CLOTS IS IDENTIFIED IN THE DEVICE LABELING AS POSSIBLE ADVERSE EVENTS/COMPLICATIONS.

    Description of Event or Problem · 0

    A 67-YEAR-OLD FEMALE WITH DEEP VEIN THROMBOSIS WAS TAKEN IN BY INTERVENTIONAL RADIOLOGY. INFERIOR VENA CAVA (IVC) THROMBUS WAS OBSERVED ON THE COMPUTED TOMOGRAPHY SCAN. THE PHYSICIAN WAS CONFIDENT THAT CLOT WAS ISOLATED TO THE COMMON ILIAC VEIN WITH POSSIBLE THROMBUS AT THE CONFLUENCE. THE PATIENT WAS INITIALLY PLACED ON ANTICOAGULATION, BUT AFTER A WEEK, THE DECISION WAS MADE TO PERFORM A MECHANICAL THROMBECTOMY. A VENOGRAM WAS PERFORMED CONFIRMING THE CLOT LOCATION, IT ALSO REVEALED A SMALL PULMONARY EMBOLISM. RIGHT VENTRICLE DILATION MAY HAVE BEEN PRESENT, BUT THE CLOT WAS TOO DISTAL TO WARRANT INTERVENTION. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT PERFORMED PRE-PROCEDURE TO FURTHER CONFIRM THE CLOT LOCATION AND EXTENT. THE PHYSICIAN PERFORMED 2 PASSES WITH THE CLOTTRIEVER BOLD CATHETER (CT BOLD). THIS REMOVED SMALL AMOUNTS OF ACUTE CLOT AND THE PHYSICIAN DECIDED TO PERFORM IVUS. FREE-FLOATING THROMBUS WAS BRIEFLY OBSERVED BUT DUE TO ENVIRONMENTAL REASONS, IT WAS DIFFICULT TO REPEAT OR PERFORM SYSTEMATIC IVUS UTILIZATION. 2 MORE PASSES WERE COMPLETE WITH MINIMAL CLOT REMOVED. VENOGRAPHY WAS PERFORMED WHICH REVEALED THAT THEY MAY HAVE MOBILIZED THROMBUS INTO AND THROUGH THE IVC ALONG WITH DILATION OF THE COMMON ILIAC VEIN AND EXTERNAL ILIAC VEIN. STAGNANT CONTRAST WAS ALSO SEEN. BALLOON ANGIOPLASTY WAS APPLIED IN THE ILIOFEMORAL SEGMENTS, AND 2 MORE PASSES WERE PERFORMED WHICH YIELDED LARGER ACUTE CLOT HAULS. A STENT WAS NOT PLACED. AT THIS POINT, THE PATIENT BEGAN THROWING UP AND COMPLAINED OF NAUSEA. THE PHYSICIAN BELIEVED THIS WAS DUE TO OVER-SEDATION AND THE PROCEDURE WAS CONCLUDED. AS SOON AS THE PATIENT WAS MOVED TO THE TRANSPORT BED, THE PATIENT BECAME IRRITABLE AND DISORIENTED. THE PATIENT BEGAN TO DECOMPENSATE, AND A RAPID RESPONSE WAS CALLED. THE PATIENT REGAINED CONSCIOUSNESS AND WAS VOCAL BUT DISORIENTED. A PULMONARY EMBOLISM WAS CONFIRMED IN THE RIGHT INTERLOBAR AND TRUNCUS ANTERIOR. THE PATIENT CRASHED AGAIN AND TPA WAS ADMINISTERED. THE PATIENT WAS MOVED TO THE MEDICAL INTENSIVE CARE UNIT AND EVENTUALLY TRANSFERRED TO ANOTHER FACILITY WITH EXTRACORPOREAL MEMBRANE OXYGENATION CAPABILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573979 CLOTTRIEVER BOLD CATHETER PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 00850291007314

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| L| H CLOTTRIEVER SHEATH, 13 FR