BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTISAN

    MDR report key: 2392099 · Received December 21, 2011

    Report

    Report Number
    3006026430-2011-00006
    Event Type
    Death
    Date Received
    December 21, 2011
    Date of Event
    November 22, 2011
    Report Date
    December 20, 2011
    Manufacturer
    HANSEN MEDICAL
    Product Code
    DXX
    PMA / PMN Number
    K102168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HANSEN MEDICAL BELIEVES THIS INCIDENT IS NOT RELATED TO EARTISAN'S PERFORMANCE DUE TO THE REPORTED KINK IN THE INTRODUCER WHICH IS NOT A HANSEN PRODUCT. THERE WERE NO PRODUCT MALFUNCTIONS REPORTED AND THE MFG RECORDS INDICATE ALL PRODUCTS RELEASED FROM THIS LOT PASSED FINAL FUNCTIONAL TESTING AND VISUAL INSPECTION. ADDITIONALLY, TIMING OF THE EVENT COULD NOT BE ESTABLISHED WHETHER THE PERFORATION OCCURRED DURING THE INITIAL INSERTION OF THE 14 F INTRODUCER OR DURING THE SECOND ATTEMPT WITH ALL 3 DEVICES. BASED ON THE INFO AND STATEMENT BY THE PHYSICIAN, "ALL 3 DEVICES MAY HAVE CONTRIBUTED TO THE EVENT," HANSEN MEDICAL 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)(6) 2011, BEFORE THE ARTISAN CATHETER WAS INSERTED, THE PHYSICIAN FELT RESISTANCE DURING INITIAL INSERTION OF A 14 F INTRODUCER INTO THE PT'S LEFT LEG AND WAS UNABLE TO PASS THE ILIAC BIFURCATION. HANSEN MEDICAL WAS ABLE TO DISCUSS WITH THE PHYSICIAN INVOLVED ON (B)(4) 2011. THE PHYSICIAN STATED HE HAD DIFFICULTY WITH THE 14 F INTRODUCER AND NOTICED A KINK IN THE INTRODUCER. HE PULLED BACK THE INTRODUCER AND INSERTED THE EARTISAN CATHETER WITH THE ABLATION CATHETER (COOLPATH) SEATED INSIDE. HE STATED THE COOLPATH CATHETER WAS EXTENDED DISTAL TO THE EARTISAN TO ASSIST WITH NAVIGATING IN THE VASCULATURE AND ATTEMPTED TO CROSS THE ILIAC BIFURCATION. HE STILL HAD DIFFICULTY ADVANCING THE CATHETER AND FELT MORE RESISTANCE THAN NORMAL. A PERFORATION WAS SUSPECTED. THE PERFORATION WAS DIAGNOSED WITH ULTRASOUND AND CONFIRMED DURING SURGERY. PT EXPIRED POST SURGERY. IT WAS UNCLEAR WHEN THE PERFORATION OCCURRED. THERE WAS NO PRODUCT MALFUNCTION REPORTED WITH EITHER THE EARTISAN OR THE COOLPATH CATHETER. MD STATED HE MAY HAVE EXERTED MORE FORCE THAN REQUIRED ON THE CATHETERS AND ALL THREE DEVICES MAY HAVE CONTRIBUTED TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTISAN CATHETER, STEERABLE DXX HANSEN MEDICAL 04453-0001 20110801

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| R 14F INTRODUCER| ST JUDE COOLPATH ABLATION CATHETER