BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTISAN

    MDR report key: 2125591 · Received June 3, 2011

    Report

    Report Number
    3006026430-2011-00003
    Event Type
    Death
    Date Received
    June 3, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    HANSEN MEDICAL
    Product Code
    DXX
    PMA / PMN Number
    K102168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IFU LISTS PERICARDIAL EFFUSION AND ESOPHAGEAL FISTULA AS A POTENTIAL ADVERSE EVENT FOR THE DEVICE. INITIAL REVIEW OF EVENT DETERMINED REPORTING NOT NECESSARY. MDR SUBSEQUENTLY GENERATED AFTER FURTHER REVIEW AND COMPARISON WITH OTHER CASES WITH A SIMILAR OUTCOME.

    Description of Event or Problem · 1

    PATIENT PRESENTED 1 WEEK AFTER LEFT SIDED PROCEDURE WITH DIFFICULTY SWALLOWING AND CHEST PAINS. NO TREATMENT PERFORMED AND ANOTHER WEEK LATER REPRESENTED, WITH SAME SYMPTOMS AND DIAGNOSIS OF A SMALL EFFUSION. EFFUSION WAS TREATED WITH A PERICARDIOCENTESIS. WHILE IN RECOVERY PATIENT HAD A STROKE, AND SUBSEQUENT IMAGING REVEALED AN ESOPHAGEAL FISTULA. PATIENT DIED SHORTLY AFTER STROKE. HANSEN CATHETER WAS DELIVERY CATHETER FOR CELSIUS IRRIGATED ABLATION CATHETER. CATHETERS WERE NOT RETURNED FOR INVESTIGATION. INDEX PROCEDURE WAS UNREMARKABLE, BUT INCLUDED POSTERIOR WALL BURNS AT 40W. PATIENT WAS ALSO REPORTED TO SUFFER FROM CROHN'S DISEASE. THERE WERE 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| H| L| R CELSIUS THERMOCOOL ABLATION CATHETER