BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNADO EMBOLIZATION COIL

    MDR report key: 10648265 · Received October 7, 2020

    Report

    Report Number
    MW5097139
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    October 3, 2020
    Report Date
    October 5, 2020
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COIL WAS DEPLOYED AND IS DESIGNED TO COIL UP. COIL REMAINED MOSTLY STRAIGHT. DR. (B)(6) DID NOT WANT TO BLOCK THE HEPATIC ARTERY AND POSSIBLY CAUSE THROMBOSIS. COIL RETRIEVAL RESULTED IN THE EXTERIOR UNWINDING AND THE INNER CORE OF THE COIL REMAINING. NO HARM TO PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104747 TORNADO EMBOLIZATION COIL DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD COOK MEDICAL LLC MWCE-35-8/5-TORNADO G10412

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR