BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTISAN

    MDR report key: 2288363 · Received October 4, 2011

    Report

    Report Number
    3006026430-2011-00005
    Event Type
    Death
    Date Received
    October 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    September 29, 2011
    Manufacturer
    HANSEN MEDICAL
    Product Code
    DXX
    PMA / PMN Number
    K102168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN STATED THE SENSEI SYSTEM AND CATHETER PERFORMED AS INTENDED AND THERE WERE NO MALFUNCTIONS OR PRODUCT PROBLEMS. THE CATHETER WAS UNABLE TO BE EVALUATED BECAUSE IT WAS DISCARDED. ALL SENSEI SYSTEMS AND ARTISAN CATHETERS ARE 100% INSPECTED AND EVALUATED PRIOR TO FINAL RELEASE.

    Description of Event or Problem · 1

    PER REPORT, A MANUAL LEFT ATRIAL ABLATION PROCEDURE TO ABLATE THE PT WAS UNSUCCESSFULLY ATTEMPTED ON (B)(6) 2010. A SECOND CRYOABLATION PROCEDURE WAS PERFORMED UNSUCCESSFULLY ON (B)(6) 2010. FOLLOWING UNSUCCESSFUL CRYOABLATION ATTEMPT, THE PROCEDURE WAS CONVERTED TO MANUAL RF ABLATION. A THIRD PROCEDURE WAS PERFORMED ON (B)(6) 2011 USING THE SENSEI SYSTEM AS THE DELIVERY SYSTEM FOR THE ABLATION CATHETER. THE PT WAS DISCHARGED WITHOUT EVENT AND NO ACUTE COMPLICATIONS WERE REPORTED. PT PRESENTED APPROX (B)(6) 2011 WITH BREATHING DIFFICULTIES AND ALTERED MENTAL STATUS. ENDOSCOPY WAS UNREMARKABLE PER REPORT. CT WAS PERFORMED ON HEAD AND THORAX WHICH DEMONSTRATED PRESENCE OF AIR IN THE LEFT ATRIUM AND BRAIN. ESOPHAGEAL FISTULA WAS PRESUMED BUT REPAIR WAS NOT PURSUED. PT EXPIRED (B)(6) 2011. PHYSICIAN STATED THAT NEITHER THE SENSEI SYSTEM NOR ARTISAN CATHETER CAUSED THE REPORTED ADVERSE EVENT AND THAT THE SYSTEM AND CATHETER PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTISAN CATHETER, STEERABLE DXX HANSEN MEDICAL 08180

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H