BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 4046810 · Received August 26, 2014

    Report

    Report Number
    3006026430-2014-00003
    Event Type
    Injury
    Date Received
    August 26, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 26, 2014
    Manufacturer
    HANSEN MEDICAL, INC.
    Product Code
    DXX
    PMA / PMN Number
    K102168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AND STATEMENT BY THE PHYSICIAN, THAT SENSEIX SYSTEM DID CONTRIBUTE TO THE ADVERSE EVENT SINCE IT WAS BEING USED AT THE TIME OF THE EVENT HANSEN MEDICAL IS REPORTING THIS CASE.

    Description of Event or Problem · 1

    THE PHYSICIAN HAD COMPLETED THE BULK OF THE PROCEDURE, ABLATING THE LIPV, RIPV, RSPV, ROOF LINE, AND MITRAL LINE. WHILE THE PHYSICIAN WAS TOUCHING UP A FEW AREAS ON THE ANTERIOR WALL OF THE LA HE NOTICED A PERICARDIAL EFFUSION ON ICE. IT WAS REPORTED THAT THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING, IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518040 NONE DXX HANSEN MEDICAL, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R LASSO CATHETER ECO-BIOSENSE WEBSTER| NAVX MAPPING SYSTEM| ST. JUDE MEDICAL