BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOTTRIEVER XL CATHETER

    MDR report key: 20052407 · Received August 23, 2024

    Report

    Report Number
    3020347218-2024-00039
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 23, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007277
    PMA / PMN Number
    K223210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. 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 VENOUS CUTDOWN WAS THE RESULT OF AN OVERFILLED COLLECTION BAG. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    AN INDIVIDUAL WITH INFERIOR VENA CAVA (IVC) AND EXTERNAL ILIAC DEEP VEIN THROMBOSIS (DVT) UNDERWENT A THROMBECTOMY WITH THE CLOTTRIEVER XL CATHETER (CTXL). INTRAVASCULAR ULTRASOUND WAS PERFORMED TO CONFIRM THE THROMBUS LOCATION AND THE SIZE OF THE POPLITEAL VEIN AND IVC. THERE WAS A SMALL CLOT IN THE EXTERNAL ILIAC, BUT THE MAJORITY OF THE CLOT BURDEN WAS IN THE INFRARENAL AREA OF THE IVC. THE POPLITEAL MEASURED 10 MM WHICH IS THE MINIMUM SIZE FOR USAGE OF THE CTXL AND THE IVC MEASURED APPROXIMATELY 20 MM. DURING THE FIRST PASS, THE CTXL ENGAGED CLOT BUT WHEN THE CTXL WAS BROUGHT INTO THE SHEATH, THE DISTAL END OF THE CATHETER BECAME STUCK BEFORE ENTERING THE CLOTTRIEVER 16FR SHEATH. THE PHYSICIAN ATTEMPTED TO REMOVE IT BUT WAS ULTIMATELY UNSUCCESSFUL. THE DISTAL END WAS OVERFILLED WITH CLOT AND WAS TOO BIG TO REMOVE. THE VASCULAR TEAM WAS CALLED IN AND A CUTDOWN WAS PERFORMED TO REMOVE THE CATHETER FROM THE BODY. THE PROCEDURE UNFORTUNATELY RESULTED IN A SMALL SEGMENT OF VESSEL BEING DAMAGED WHEN THE CTXL WAS RETRACTED. A GORE VIABAHN STENT WAS SUTURED TO THE PATIENTS' POPLITEAL VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072528 CLOTTRIEVER XL CATHETER PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 41-102 24020020 00850291007277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Disability| R| H CLOTTRIEVER SHEATH, 16 FR