BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERAPY COOL PATH CATHETER

    MDR report key: 2394769 · Received December 27, 2011

    Report

    Report Number
    MW5023633
    Event Type
    Other
    Date Received
    December 27, 2011
    Date of Event
    December 27, 2011
    Report Date
    December 27, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRF
    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 EVIDENCE OF HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL PATH CATHETER EP CATHETER DRF ST. JUDE MEDICAL ISI-83327 3517903

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR