BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 2765071 · Received September 25, 2012

    Report

    Report Number
    3006026430-2012-00002
    Event Type
    Injury
    Date Received
    September 25, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 25, 2012
    Manufacturer
    HANSEN MEDICAL, INC.
    Product Code
    DXX
    PMA / PMN Number
    K102168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO PRODUCT MALFUNCTIONS REPORTED. THE ARTISAN NAVIGATION CATHETER PERFORMED ACCORDING TO THE APPROVED INSTRUCTION FOR USE TO NAVIGATE AND FACILITATE DELIVERY OF THE ST. JUDE MEDICAL, THERAPEUTIC ABLATION CATHETER. ALL ARTISAN CATHETERS ARE TESTED FOR PERFORMANCE PRIOR TO RELEASE. THE ARTISAN CATHETER DOES NOT PROVIDE ENERGY FOR ABLATION. BASED ON THE INFO AND STATEMENT BY THE PHYSICIAN, HANSEN MEDICAL IS REPORTING THIS CASE.

    Description of Event or Problem · 1

    A NAVIGATION COOLPATH DUO ABLATION CATHETER FROM ST. JUDE MEDICAL INSERTED IN AN ARTISAN CATHETER WAS USED IN AN AF ABLATION PROCEDURE. WHILE ABLATING THE ROOF LINE OF THE LEFT ATRIUM, THE PHYSICIAN NOTED THE PT WAS COUGHING DURING THE PROCEDURE. IT WAS REPORTED THAT THE PT BECAME HEMODYNAMICALLY UNSTABLE AND A CARDIAC TAMPONADE WAS CONFIRMED WITH TRANSESOPHAGEAL ECHOCARDIOGRAM. CARDIAC SURGERY WAS PERFORMED TO STABILIZE THE PT. PT WAS TRANSFERRED TO THE ICU, IN STABLE CONDITION. THERE WERE NO PRODUCT MALFUNCTIONS REPORTED AND THE ST. JUDE MEDICAL COOLPATH DUO ABLATION CATHETER AND THE ARTISAN CATHETER PERFORMED ACCORDING TO THE APPROVED INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTISAN NAVIGATION CATHETER, STEERABLE DXX HANSEN MEDICAL, INC. 04453-0001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R ST JUDE MEDICAL, COOLPATH DUO ABLATION CATHETER| DECAPOLAR CS CATHETER| LASSO MAPPING CATHETER