BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN EXTEND

    MDR report key: 4994525 · Received August 6, 2015

    Report

    Report Number
    3006026430-2015-00003
    Event Type
    Injury
    Date Received
    August 6, 2015
    Date of Event
    July 27, 2015
    Report Date
    August 6, 2015
    Manufacturer
    HANSEN MEDICAL, INC.
    Product Code
    DRA
    PMA / PMN Number
    K122275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO PRODUCT MALFUNCTIONS REPORTED. THE ARTISAN EXTEND NAVIGATION CATHETER PERFORMED ACCORDING TO THE APPROVED INSTRUCTION FOR USE. ALL ARTISAN EXTEND CATHETERS ARE TESTED FOR PERFORMANCE PRIOR TO RELEASE. THE ARTISAN EXTEND CATHETER DOES NOT PROVIDE ENERGY FOR ABLATION. BASED ON THE INFO AND STATEMENT BY THE PHYSICIAN, THE DEVICE WAS AN "UNK" CONTRIBUTOR TO THE EVENTS, HANSEN MEDICAL IS REPORTING THIS CASE. DEVICE WAS DISCARDED AT THE TIME OF THE PROCEDURE AND WAS NOT RETRIEVABLE FOR INVESTIGATION. THE PT RECOVERED THE FOLLOWING DAY.

    Description of Event or Problem · 1

    THE PHYSICIAN COMPLETED A PROCEDURE UNEVENTFULLY USING THE SENSEI AND ARTISAN EXTEND CATHETER. FOR THE PROCEDURE, THE PHYSICIAN PLACED 4 SHEATHS INTO THE PT'S RIGHT VEIN (14F, 11F, 10F, 7F). WHILE IN RECOVERY, APPROXIMATELY 1 HOUR POST PROCEDURE THE PT DEVELOPED A RIGHT GROIN/LEG ISSUE. A VASCULAR SURGEON WAS CONSULTED. HE DETERMINED THE PT DEVELOPED A TOTAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND DECIDED TO INTERVENE TO REMOVE THE BLOCKAGE. WHILE ADMINISTERING ANESTHESIA FOR THE VASCULAR INTERVENTION, THE ANESTHESIOLOGIST NOTICED THE PT WAS MORE DIFFICULT TO MANAGE AND A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED. THE PT DEVELOPED CARDIAC TAMPONADE. THE PHYSICIAN WAS CALLED AND PERFORMED A PERICARDIOCENTESIS AND DRAINED APPROXIMATELY 450CC. THE TAMPONADE OCCURRED APPROXIMATELY 3 HOURS POST EP PROCEDURE. NO EFFUSION WAS SEEN ON ICE AT THE COMPLETION OF THE EP PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PT IS DOING MUCH BETTER TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520640 ARTISAN EXTEND NAVIGATION CATHETER, STEERABLE DRA HANSEN MEDICAL, INC. 04454 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R ABLATION CATHETER - TACTICATH