BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOTTRIEVER CATHETER, 16 MM

    MDR report key: 11669206 · Received April 15, 2021

    Report

    Report Number
    11669206
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    June 9, 2020
    Report Date
    July 14, 2020
    Manufacturer
    INARI MEDICAL INC
    Product Code
    QEW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE INARI DEVICE WAS USED TO MAKE ONE PASS, THROMBUS NOTED. THERE WAS SOME RESISTANCE DURING THE SECOND PASS, THOUGHT TO BE CHRONIC THROMBUS. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER THROUGH THE SHEATH, WHICH MET RESISTANCE. USING FLUOROSCOPY, IT WAS DETERMINED THAT THE CORING ELEMENT DID NOT COMPLETELY DECOMPRESS DESPITE DOING SO EXTERNALLY. THE CORING ELEMENT WAS LODGED IN THE BASKET OF THE SHEATH. WHEN ATTEMPTING TO PULL THE CATHETER OUT, THE BASKET OF THE SHEATH SEPARATED FROM THE SHEATH ITSELF. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569008 CLOTTRIEVER CATHETER, 16 MM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW INARI MEDICAL INC 40-102 19110008

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA