BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMBECTOMY DEVICE

    MDR report key: 13043078 · Received December 17, 2021

    Report

    Report Number
    MW5106151
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    December 1, 2021
    Report Date
    December 15, 2021
    Manufacturer
    INARI MEDICAL - OAK CANYON
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INARI THROMBECTOMY DEVICE WAS SEVERED AS IT WAS BEING REMOVED FROM A VEIN. IT WAS NEVER DISLODGED OR LOST IN THE VEIN. THE PHYSICIAN WAS ABLE TO SAFELY REMOVE ALL PARTS OUT OF THE DEVICE AND HEMOSTASIS WAS ACHIEVED BY INSERTING A NEW VASCULAR SHEATH. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932540 THROMBECTOMY DEVICE CATHETER, EMBOLECTOMY DXE INARI MEDICAL - OAK CANYON

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Unknown