BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 1081315 · Received July 24, 2008

    Report

    Report Number
    3006026430-2008-00010
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    HANSEN MEDICAL, INC.
    Product Code
    DRA
    PMA / PMN Number
    K052480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFO GATHERED FROM THE SURGERY, IT IS BELIEVED THAT WHEN THE DOCTOR WAS ATTEMPTING TO MAP THE LEFT SUPERIOR VEIN, THE CATHETER WAS ACTUALLY POSITIONED AROUND THE APPENDAGE.

    Description of Event or Problem · 1

    EARLY IN THE MAPPING PART OF A LEFT ATRIAL PROCEDURE, WHILE ATTEMPTING TO GATHER POINTS FOR THE LEFT SUPERIOR PULMONARY VEIN, THE PT'S BLOOD PRESSURE DROPPED AND AN EFFUSION WAS CONFIRMED WITH ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PT'S BLOOD PRESSURE, BUT THE EFFUSION DID NOT RESOLVE. ANTICOAGULATION WAS REVERSED, AND THE PERICARDIAL TAP CONTINUED TO PRESENT FLUID. PT'S BLOOD PRESSURE DROPPED AND SURGERY WAS PERFORMED. A PERFORATION AT THE BASE OF THE LEFT ATRIAL APPENDAGE WAS REPAIRED. THE PT RECOVERED FULLY AND WAS DISCHARGED ON A NORMAL SCHEDULE. THERE WAS NO MALFUNCTION OF THE DEVICE AND THE EVENT WAS DETERMINED TO BE PROCEDURE RELATED. THE IFU LISTS PERICARDIAL EFFUSION AS A POTENTIAL ADVERSE EVENT FOR THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention