BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELSIUS THERMOCOOL CATHETER

    MDR report key: 716750 · Received May 19, 2006

    Report

    Report Number
    2029046-2006-00030
    Event Type
    Other
    Date Received
    May 19, 2006
    Date of Event
    May 8, 2006
    Report Date
    May 11, 2006
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERMCOOL CATHETER WAS USED ON PATIENT DURING AFIB ABLATION PROCEDURE. AFTER PATIENT WAS RETURNED TO RECOVERY UNIT, IT WAS DISCOVERED THAT PATIENT WAS SHORT OF BREATH AND WHEEZY. THE PATIENT WAS DIAGNOSED WITH TRANSIENT PULMONARY EDEMA. HE WAS GIVEN 40 MG FUROSEMIDE. THE PATIENT REPORTED HE WAS FINE IN A LATER TELEPHONE FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELSIUS THERMOCOOL CATHETER ELECTROPHYSIOLOGY CATHETER DRF BIOSENSE WEBSTER, INC. D-1189-02-S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other