BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST

    MDR report key: 12007903 · Received June 16, 2021

    Report

    Report Number
    12007903
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    April 23, 2021
    Report Date
    June 10, 2021
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN LP CLOSUREFAST ENDOVENOUS RADIOFREQUENCY ABLATION (RFA) CATHETER UNABLE TO PASS OVER WIRE DURING SURGICAL/ MEDICAL PROCEDURE. A DIFFERENT CATHETER WAS USED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909997 CLOSUREFAST ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA