BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INARI CLOTTRIEVER SHEATH

    MDR report key: 11945910 · Received June 7, 2021

    Report

    Report Number
    11945910
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 2, 2021
    Manufacturer
    INARI MEDICAL INC
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLOTTRIEVER SHEATH WAS NOT WORKING PROPERLY AFTER ONE USE. WOULD NOT RECAPTURE THE SHEATH DURING A THROMBECTOMY. CLOTTRIEVER WAS NOT USED AND REMOVED FROM FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847654 INARI CLOTTRIEVER SHEATH CATHETER, EMBOLECTOMY DXE INARI MEDICAL INC 50-101

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA