BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOTTRIEVER XL CATHETER

    MDR report key: 20017755 · Received August 21, 2024

    Report

    Report Number
    3020347218-2024-00037
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 15, 2024
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007277
    PMA / PMN Number
    K223210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, OR DESIGN. THE CASE WAS REVIEWED BY INARI'S CHIEF MEDICAL OFFICER, WHO CONCLUDED THAT THE PATIENT'S DETERIORATION WAS THE RESULT OF INADVERTENT 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 MALE PATIENT UNDERWENT A THROMBECTOMY WITH THE CLOTTRIEVER XL CATHETER (CTXL). ACCESS WAS OBTAINED IN THE RIGHT INTERNAL JUGULAR AND THE PROTRIEVE SHEATH WAS PLACED. TWO PASSES WERE PERFORMED WHICH REMOVED CLOT BURDEN. HOWEVER, ON THE THIRD PASS THE CTXL BECAME OVERLOADED AND THE MID TO DISTAL PORTION OF THE COLLECTION BAG BECAME STUCK IN THE PROTRIEVE BASKET. A PROTRIEVE ASPIRATION WAS PERFORMED AND THE PROTRIEVE WAS REMOVED WITH THE CTXL WHILE UNDER ASPIRATION. THE PATIENT THEN BEGAN TO DECOMPENSATE WITH A DROP IN THEIR OXYGEN SATURATION AND HEART RATE. CHEST COMPRESSIONS WERE PERFORMED, AND THE PATIENT WAS PREPPED FOR A PULMONARY EMBOLISM THROMBECTOMY. A CODE WAS CALLED WITH ADDITIONAL CHEST COMPRESSIONS. THE PATIENT WAS AGITATED AND BEGAN MOVING WHICH LED TO ANESTHESIA TO INTUBATE THE PATIENT. CROSSING THE RIGHT HEART WAS DIFFICULT DUE TO THE CHEST COMPRESSIONS BUT EVENTUALLY AN ASPIRATION WAS PERFORMED IN THE RIGHT PULMONARY ARTERY. A LARGE CLOT BURDEN WAS ASPIRATED WHICH WAS ACUTE-ON-CHRONIC. THE PROCEDURE CONTINUED AND ONE MODEST SIZED CLOT WAS REMOVED FROM THE LEFT PULMONARY ARTERY. FINAL IMAGING REVEALED THAT BOTH LOBES FILLED COMPLETELY. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION AND WAS TRANSFERRED TO ANOTHER FACILITY. THE PATIENT WAS LAST REPORTED TO HAVE BEEN AWAKE AND RESPONDING TO PROMPTS. THE PATIENT WAS EVENTUALLY PLACED BACK UNDER SEDATION TO CONTROL HIS VITALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117872 CLOTTRIEVER XL CATHETER PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL, INC. 41-102 24040125 00850291007277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening| H| R FLOWSAVER| INTRI24 SHEATH| PROTRIEVE SHEATH| TRIEVER24