BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELSIUS TEMPERATURE SENSING CATHETER

    MDR report key: 323789 · Received March 30, 2001

    Report

    Report Number
    2020638-2001-00003
    Event Type
    Other
    Date Received
    March 30, 2001
    Date of Event
    November 16, 2000
    Report Date
    February 28, 2001
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT EXPERIENCED VENTRICULAR FIBRILLATION AFTER SEVERAL CLEAN BURNS WERE OBTAINED. THREE INCIDENCES OF V-FIB OCCURRED. AS A RESULT, THE PHYSICIAN TERMINATED THE ABLATION PROCEDURE AND THE V-FIB WAS SELF TERMINATED. ECHO WAS PERFORMED AND NO PERFORATION WAS OBSERVED. PT WAS DISCHARGED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14208 CELSIUS TEMPERATURE SENSING CATHETER THERAPEUTIC CATHETER DRF BIOSENSE WEBSTER, INC. D-1198-04-S NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening OTHER MEDICAL DEVICES: EPT DIAGNOSTIC CATH.