BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIOBE MAGNETIC NAVIGATION SYSTEM

    MDR report key: 824354 · Received March 5, 2007

    Report

    Report Number
    3003084417-2007-00001
    Event Type
    Death
    Date Received
    March 5, 2007
    Date of Event
    February 7, 2007
    Report Date
    March 5, 2007
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    MQB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NIOBE SYSTEM IS NOT AN INVASIVE PRODUCT AND PERFORMED AS INTENDED. THE ADVERSE EVENT THAT OCCURRED MAY HAVE BEEN CAUSED BY ANOTHER PRODUCT USED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    THE PROCEDURE PROCEEDED ROUTINELY WITH THE PHYSICIAN PERFORMING MAPPING (ST JUDE NAV-X SYSTEM) AND ABLATION IN THE LEFT ATRIUM BOTH USING A BIOSENSE WEBSTER RMT CATHETER. DUE TO DIFFICULTY IN NAVIGATION OF THE MAGNETIC CATHETER TO THE RIGHT-SIDED PULMONARY VEINS ( REPORTED TRANSSEPTAL SHEATH POSSIBLY PREVENTING CATHETER FROM TURNING IN THE CORECT DIRECTION), THE PRIMARY PHYSICIAN DECIDED TO SWITCH TO A CRYOABLATION CATHETER FROM CRYOCATH. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THIS TIME. APPROXIMATELY 15-30 MINUTES AFTER REMOVAL OF THE RMT CATHETER, DIFFICULT MANUAL MANIPULATION OF THE SHEATH AND CRYOCATHETER BY AN ELECTROPHYSIOLOGY FELLOW PHYSICIAN WAS NOTED WITH A SUDDEN APPEARANCE OF THE CATHETER OUTSIDE THE CARDIAC 3-D MAP ON NAV-X. EXTRACARDIAC POSITION WAS CONFIRMED WITH FLUOROSCOPY AND THE PATIENT HAD A HEMODYNAMIC DETERIORATION WITH CHANGES IN BOTH HEART RATE AND BLOOD PRESSURE. EMERGENCY MEASURES ENSUED. PER REPORT, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR DEFINITIVE CARE. FINAL PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIOBE MAGNETIC NAVIGATION SYSTEM STEERABLE CATHETER CONTROL SYSTEM MQB STEREOTAXIS, INC. 001-003000-2 0013

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| L| R CRYOCATH CRYOABLATION CATHETER| ST. JUDE NAV-X SYSTEM| BIOSENSE WEBSTER, INC. NAVISTAR RMT CATHETER