BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 2707813 · Received August 17, 2012

    Report

    Report Number
    3006026430-2012-00001
    Event Type
    Injury
    Date Received
    August 17, 2012
    Date of Event
    July 19, 2012
    Report Date
    August 17, 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 AS INTENDED TO NAVIGATE AND FACILITATE DELIVERY OF THE ST. JUDE 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, (B)(6) IS REPORTING THIS CASE. DEVICE WAS DISCARDED AT THE TIME OF THE PROCEDURE AND WAS NOT RETRIEVABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(4) 2012, A NAVIGATION COOLPATH DUO ABLATION CATHETER FROM ST. JUDE MEDICAL INSERTED IN AN ARTISAN CATHETER WAS USED IN A AF ABLATION PROCEDURE. A PVI, ROOFLINE AND ENDOCARDIAL MITRAL ISTHMUS LINE HAD SUCCESSFULLY BEEN ABLATED IN THIS PROCEDURE. WHILE ABLATING IN THE CORONARY SINUS, A PERFORATION OCCURRED. CARDIAC SURGERY WAS PERFORMED TO SUCCESSFULLY REPAIR THE TEAR IN THE CORONARY SINUS. PT WAS TRANSFERRED TO ICU, IN STABLE CONDITION.

    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 70 YR Hospitalization| L| R SPREME JSN QUAD| ST. JUDE THERAPY COOLPATH DUO ABLATION CATHETER| REFLEXION SPIRAL (REF #: (B)(4))| (REF NO: (B)(4))| LIVEWIRE DECAPOLAR MED SWEEP (REF #: (B)(4))