BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-FLO INTRODUCER SET

    MDR report key: 1233445 · Received October 26, 2008

    Report

    Report Number
    1233445
    Event Type
    Malfunction
    Date Received
    October 26, 2008
    Date of Event
    August 5, 2008
    Report Date
    October 26, 2008
    Manufacturer
    COOK MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RADIO-OPAQUE MARKER BROKE OFF AT THE END OF THE INTRODUCER SHEATH OF THE CATHETER FOR THE PROCEDURE. IT MIGRATED TO THE RIGHT PULMONARY ARTERY. DOCTOR WAS ABLE TO SNARE WITH A BALLOON CATHETER AND REMOVE. PREVENTING HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHECK-FLO INTRODUCER SET INTRODUCER, CATHETER DYB COOK MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR