BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTISAN

    MDR report key: 2093533 · Received May 3, 2011

    Report

    Report Number
    3006026430-2011-00001
    Event Type
    Death
    Date Received
    May 3, 2011
    Date of Event
    February 9, 2011
    Report Date
    April 4, 2011
    Manufacturer
    HANSEN MEDICAL
    Product Code
    DXX
    PMA / PMN Number
    K102168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IFU LISTS ESOPHAGEAL FISTULA AS A POTENTIAL ADVERSE EVENT FOR THE DEVICE.

    Description of Event or Problem · 1

    PT PRESENTED MULTIPLE TIMES POST LEFT SIDED PROCEDURE WITH PERICARDITIS SYMPTOMS AND AF REOCCURRENCE. ON FINAL ADMITTANCE, PT WAS FEBRILE HAD MULTIPLE EMBOLIC EVENTS TO THE BRAIN AND HAD AN ACTIVE ESOPHAGEAL FISTULA. PT DIED 3 DAYS LATER AFTER LIFE SUPPORT WAS WITHDRAWN. CAUSE OF DEATH REPORTED AS MULTIPLE EMBOLIC EVENTS TO THE BRAIN. HANSEN CATHETER WAS DELIVERY CATHETER FOR CELSIUS IRRIGATED ABLATION CATHETER. CATHETERS WERE NOT RETURNED FOR INVESTIGATION. INDEX PROCEDURE WAS PROLONGED DUE TO EXTENSIVE ABLATIONS AND PERFORMED UNDER GENERAL ANESTHESIA, BUT WAS OTHERWISE UNREMARKABLE. THERE WAS NO MALFUNCTIONS OR ISSUES NOTED DURING THE INDEX ABLATION PROCEDURE AND THE DR. DID NOT ATTRIBUTE CAUSALITY TO THE CELSIUS ABLATION CATHETER NOR HANSEN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTISAN CATHETER, STEERABLE DXX HANSEN MEDICAL 04454

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death CELCIUS THERMOCOOL ABLATION CATHETER