BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSEI

    MDR report key: 1031116 · Received April 18, 2008

    Report

    Report Number
    3006026430-2008-00003
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 21, 2008
    Manufacturer
    HANSEN MEDICAL, INC.
    Product Code
    DRA
    PMA / PMN Number
    K052480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN CROSSED THE SEPTUM WITH THE ARTISAN CATHETER AND DURING NAVIGATION IN THE LEFT ATRIUM, THE PHYSICIAN NOTED THAT SENSEI SYSTEM WOULD NOT MANIPULATE THE CATHETER AS EXPECTED IN THE POSTERIOR DIRECTION. REMOVING AND REATTACHING THE ARTISAN CATHETER TO THE SENSEI SYSTEM DID NOT RESOLVE THE LACK OF POSTERIOR NAVIGATION, SO THE PHYSICIAN COMPLETED THE PROCEDURE MANUALLY. THE CATHETER WAS NOT RETURNED FOR INVESTIGATION. INVESTIGATION OF THE ROBOTIC CATHETER MANIPULATOR (RCM) COMPONENT OF THE SENSEI DID NOT FIND ANY ISSUES WHICH WOULD INDICATE THE CAUSE OF THE BEHAVIOR. THE PHYSICIAN DID NOT IDENTIFY THE SYSTEM BEHAVIOR AS THE CAUSE OF THE EFFUSION.

    Description of Event or Problem · 1

    AFTER A PROCEDURE WAS COMPLETED AND THE PT WAS IN RECOVERY, HE BECAME ACUTELY HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS IDENTIFIED VIA ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED, AND THE PT RECOVERED WITH NO FURTHER SEQUELAE. PHYSICIAN STATED THAT IT WAS UNCLEAR WHAT MAY HAVE CAUSED THE EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSEI CATHETER CONTROL SYSTEM DRA HANSEN MEDICAL, INC. 02057

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R