BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 1045351 · Received May 14, 2008

    Report

    Report Number
    3006026430-2008-00005
    Event Type
    Injury
    Date Received
    May 14, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    HANSEN MEDICAL, INC.
    Product Code
    DRA
    PMA / PMN Number
    K052480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN EFFUSION WAS OBSERVED DURING A LEFT ATRIAL PROCEDURE. ACCESS TO THE LEFT MAIN ATRIUM WAS OBTAINED WITH A SINGLE MANUAL TRANSSEPTAL PUNCTURES. THE ARTISAN CATHETER WAS ADVANCED THROUGH THE PUNCTURE AND A CIRCULAR MAPPING CATHETER WAS ADVANCED THROUGH THE SAME PUNCTURE OVER A WIRE. MAPPING OF THE LEFT ATRIUM AND WIDE CIRCLE ABLATION OF THE LEFT PULMONARY VEIN WAS BEGUN. BLOOD PRESSURE STARTED TO DROP ABOUT 20 MINUTES AFTER ENTERING THE LEFT ATRIUM. PERICARDIAL EFFUSION WAS NOTED WITH ULTRASOUND AND A PERICARDIOCENTESIS WAS PERFORMED. THE PT RECOVERED WITH NO FURTHER SEQUELAE. ATTENDING PHYSICIAN IS UNCERTAIN WHAT CAUSED THE EFFUSION. THERE WAS NO MALFUNCTION OF THE DEVICE IDENTIFIED.

    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 75 YR Life Threatening| R