BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY COOL PATH CATHETER

    MDR report key: 2312752 · Received October 24, 2011

    Report

    Report Number
    MW5022823
    Event Type
    Injury
    Date Received
    October 24, 2011
    Date of Event
    October 11, 2011
    Report Date
    October 13, 2011
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERAPY COOL PATH CATHETER IRRIGATION PORT BROKE OFF CATHETER DURING PROCEDURE. REPLACED WITH NEW CATHETER. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL PATH CATHETER EP CATHETER DRF ST JUDE MEDICAL IBI-83327 3461360

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention