BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 2092589 · Received May 3, 2011

    Report

    Report Number
    3006026430-2011-00002
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 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 TO MULTIPLE TIMES POST LEFT SIDED PROCEDURE WITH DIFFICULTY SWALLOWING AND CHEST PAINS. ON FINAL ADMITTANCE, PT WAS FEBRILE, HAD EXPERIENCED ONE TIA AND HAD AN ACTIVE ESOPHAGEAL FISTULA. AN ABSCESS WAS SURGICALLY REMOVED FROM BETWEEN THE HEART AND THE ESOPHAGUS. AS OF LAST REPORT, PT WAS STILL IN THE HOSP RECOVERING FROM SURGERY AND INFECTION. HANSEN CATHETER WAS DELIVERY CATHETER FOR CELSIUS IRRIGATED ABLATION CATHETER. PROCEDURE PERFORMED UNDER GENERAL ANESTHESIA. CATHETERS WERE NOT RETURNED FOR INVESTIGATION. INDEX PROCEDURE WAS UNREMARKABLE. THERE WAS NO MALFUNCTIONS OR ISSUES WITH 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 55 YR Hospitalization| L| R CELCIUS THERMOCOOL ABLATION CATHETER