BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN EXTEND CONTROL CATHETER

    MDR report key: 4203024 · Received October 23, 2014

    Report

    Report Number
    3006026430-2014-00009
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    June 27, 2014
    Report Date
    October 23, 2014
    Manufacturer
    HANSEN MEDICAL, INC.
    Product Code
    DRA
    PMA / PMN Number
    K122275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO PRODUCT MALFUNCTIONS REPORTED. ALL ARTISAN CATHETERS ARE TESTED FOR PERFORMANCE PRIOR TO RELEASE. BASED ON THE PHYSICIAN'S STATEMENT THAT HE WAS UNSURE WHETHER THE GUIDEWIRE OR THE WORKING CATHETER/ARTISAN EXTEND SHEATH COMBINATION CAUSED OR CONTRIBUTED TO THE PERFORATION, HANSEN MEDICAL IS REPORTING THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR ENCOUNTERED A TORTUOUS ILIAC VEIN AND WAS ATTEMPTING TO ADVANCE THE WORKING CATHETER AND ARTISAN SHEATH PAST THE AREA OF TORTUOSITY. THE DOCTOR WAS UNABLE TO ADVANCE THE SHEATH AND REMOVED THE WORKING CATHETER AND ARTISAN EXTEND AND INTRODUCE A GLIDEWIRE TO ATTEMPT TO NAVIGATE THROUGH THE ILIAC'S AND THE INFERIOR VENA CAVA INTO THE PATIENTS RIGHT ATRIUM. WHILE THE DOCTOR WAS MANIPULATING THE GLIDEWIRE THE PATIENT'S BLOOD PRESSURE DROPPED AND A TEAR IN THE INFERIOR VENA CAVA BETWEEN L3 AND L4 ABOVE THE VENA CAVA BIFURCATION WAS CONFIRMED WITH SHOT OF VENOGRAM. IT WAS REPORTED THAT THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND A PATIENT WAS SENT TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674902 ARTISAN EXTEND CONTROL CATHETER ARTISAN EXTEND DRA HANSEN MEDICAL, INC. 12412 13200

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other