BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAILBLAZER

    MDR report key: 12391206 · Received August 31, 2021

    Report

    Report Number
    12391206
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 13, 2021
    Report Date
    August 23, 2021
    Manufacturer
    COVIDIEN LP
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN LP TRAILBLAZER¿ SUPPORT CATHETER BROKE OFF IN PATIENT. THE FAULTY CATHETER WAS IMMEDIATELY RETRIEVED, AND WITHOUT ANY INJURY TO PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300269 TRAILBLAZER CATHETER, PERCUTANEOUS DQY COVIDIEN LP SC-035-150 B170572

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA