BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTISAN

    MDR report key: 2125508 · Received June 3, 2011

    Report

    Report Number
    3006026430-2011-00004
    Event Type
    Death
    Date Received
    June 3, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    HANSEN MEDICAL
    Product Code
    DXX
    PMA / PMN Number
    K102168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. NOTE EVENT OCCURRED IN THE (B)(6) AND THAT USE IN ABLATION PROCEDURES IN 'ON-LABEL'.

    Description of Event or Problem · 1

    PATIENT PRESENTED 1 WEEK AFTER LEFT SIDED PROCEDURE WITH DYSPNEA. CT IMAGING REPORTED PNEUMOTHORAX AND PNEUMO-PERICARDIUM. GAS WAS SURGICALLY REMOVED. DURING RECOVERY, PATIENT EXPERIENCED MYOCARDIAL INFARCTION AND STROKE DUE TO AIR IN BLOOD STREAM. PATIENT SUBSEQUENTLY EXPIRED DUE TO COMPLICATIONS OF MI AND STROKE. HANSEN CATHETER WAS DELIVERY CATHETER FOR CELSIUS IRRIGATED ABLATION CATHETER. CATHETERS WERE NOT RETURNED FOR INVESTIGATION. DURING INDEX PROCEDURE, INITIAL TRANSEPTAL ACCESS ABLATIONS WITH SJM DUO WERE NOT PERFORMED IN ATRIA, BUT IN POSTERIOR PERICARDIAL SAC. (DETERMINED BY REMOVAL OF ABLATION FLUSH FLUID FROM PERICARDIAL SAC VIA PERICARDIOCENTESIS) HANSEN CATHETER WAS SUBSEQUENTLY REMOVED AND REMAINDER OF PROCEDURE WAS COMPLETED MANUALLY. THERE WAS NO MALFUNCTIONS OR ISSUES REPORTED DURING THE INDEX ABLATION PROCEDURE AND THE DR. DID NOT ATTRIBUTE CAUSALITY TO THE SJM ABLATION CATHETER NOR HANSEN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTISAN CATHETER, STEERABLE DXX HANSEN MEDICAL 04453

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| H| L| R CELCIUS THERMOCOOL ABLATION CATHETER