BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INARI CLOTTRIEVER SHEATH

    MDR report key: 12047018 · Received June 22, 2021

    Report

    Report Number
    3011525976-2021-00015
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 22, 2021
    Manufacturer
    INARI MEDICAL, INC.
    Product Code
    QEW
    UDI-DI
    00850291007109
    PMA / PMN Number
    K210190
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INARI DEVICE WAS DISCARDED BY THE USER FACILITY AND IS 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 EVENT WAS REVIEWED BY INARI'S CHIEF MEDICAL OFFICER, WHO CONCLUDED THAT THE VESSEL INJURY WAS CAUSED BY REMOVAL OF THE CLOTTRIEVER SHEATH. IT SHOULD BE NOTED THAT THE DEVICE LABELING INCLUDES THE FOLLOWING INSTRUCTIONS: PRE-DILATE THE ACCESS SITE BY ADVANCING A 16 FR OR 18 FR DILATOR, FOR THE 13 FR AND 16 FR SHEATH SYSTEMS, RESPECTIVELY, OVER THE 0.035" GUIDEWIRE AND INTO THE ACCESS SITE. VESSEL DISSECTION IS LISTED IN THE DEVICE LABELING AS A POTENTIAL COMPLICATION / ADVERSE EVENT. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    A (B)(6)-YEAR-OLD FEMALE PATIENT PRESENTED TO THE HOSPITAL WITH UPPER EXTREMITY DEEP VEIN THROMBOSIS (DVT) EXTENDING FROM THE PROXIMAL BASILIC VEIN TO THE SUBCLAVIAN. ON (B)(6) 2021, THE INARI MEDICAL CLOTTRIEVER (CT) WAS USED TO ATTEMPT TO TREAT THE DVT. AFTER ULTRASOUND-GUIDED ACCESS WAS OBTAINED, A COOK MEDICAL BENTSON WIRE GUIDE WAS ADVANCED BEFORE BEING EXCHANGED FOR A BOSTON SCIENTIFIC AMPLATZ SUPER STIFF GUIDEWIRE. A PHILLIPS VISIONS PV .035 DIGITAL IVUS CATHETER WAS THEN USED TO CONFIRM CLOT LOCATION AND VESSEL SIZE. THE VESSEL WAS DILATED WITH A 14F COONS DILATOR, THE CT SHEATH WAS INSERTED OVER THE GUIDEWIRE, AND THE CT DILATOR WAS ADVANCED. AFTER DILATION, THE PHYSICIAN BEGAN TO WITHDRAW THE CT DILATOR AND ENCOUNTERED SUBSTANTIAL RESISTANCE. THE PHYSICIAN PAUSED REMOVAL TO MAKE A SMALL INCISION IN THE VEIN BEFORE CONTINUING. WHILE ATTEMPTING TO REMOVE THE DEVICES, IT WAS NOTED THAT THE VEIN WALL WAS BEING STRIPPED. AFTER THE DEVICES WERE REMOVED, THE PHYSICIAN LIGATED THE VEIN, AND THE PROCEDURE WAS CONCLUDED. THE PHYSICIAN NOTED THAT ENGAGING THE CT DILATOR TABS DURING WITHDRAWAL MAY HAVE CAUSED THE DEVICE TO CATCH THE VEIN WALL, PULLING IT DOWN AND CATCHING IT IN THE SHEATH FUNNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942363 INARI CLOTTRIEVER SHEATH EMBOLECTOMY CATHETER QEW INARI MEDICAL, INC. 50-101 21010014 00850291007109

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention| S 14F COONS DILATOR| AMPLATZ SUPER STIFF GUIDEWIRE| COOK MEDICAL BENTSON WIRE GUIDE| PV .035 DIGITAL IVUS CATHETER