BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIOBE MAGNETIC NAVIGATION SYSTEM

    MDR report key: 863265 · Received June 8, 2007

    Report

    Report Number
    3003084417-2007-00002
    Event Type
    Injury
    Date Received
    June 8, 2007
    Date of Event
    May 3, 2007
    Report Date
    May 9, 2007
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 PATIENT WAS PARTIALLY THROUGH A PULMONARY VEIN ISOLATION PROCEDURE USING THE STEREOTAXIS SYSTEM. THE ABLATION STRATEGY WAS WIDE AREA CIRCUMFERENTIAL ISOLATION OF PULMONARY VEINS, LEFT THEN RIGHT. THE LEFT PULMONARY VEINS WERE ABOUT 90% ISOLATED AND THE PHYSICIAN WAS CONCENTRATING ON AN AREA BETWEEN THE LEFT UPPER AND LEFT LOWER VEINS, POSTERIORLY WHERE AN ELECTROGRAM AMPLITUDE PERSISTED FOLLOWING ABLATION. SEVERAL CLOSELY SPACED RADIOFREQUENCY APPLICATIONS WERE MADE, RESULTING IN VERY LOW POWER DELIVERED YET GOOD TEMPERATURE ACHIEVED. THERE WERE NO SIGNIFICANT CHANGES IN ELECTRODE IMPEDANCE. THIS SUGGESTED THE POSSIBILITY OF CHAR ON THE ELECTRODE; THE SHEATH WAS ADVANCED OVER THE ELECTRODE, WHICH WAS REMOVED FROM THE BODY, AND CHAR WAS FOUND. THE CHAR WAS CLEANED CAREFULLY OFF THE ELECTRODE WHICH WAS RE-ADVANCED INTO THE LEFT ATRIUM AND MAPPING AND ABLATION FOR ABOUT FIFTEEN MINUTES. THROUGHOUT THIS TIME, THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE STAFF RAN INTO THE SAME PROBLEM WITH LOW POWER, GOOD TEMPERATURE AND POSSIBILITY OF CHAR; DR. ASKED HIS FELLOW TO RE-ADVANCE THE SHEATH OVER THE CATHETER AND PULL THE CATHETER OUT AGAIN TO CHECK FOR CHAR. THERE WAS NONE. HOWEVER, DR. THOUGHT THE SHEATH MAY HAVE BEEN ADVANCED MORE THAN IDEAL, AND WAS RIGHT IN THE REGION WHERE HE HAD BEEN ABLATING. SHORTLY BEFORE RE-INSERTING THE CATHETER THROUGH THE SHEATH AND STARTING SOME MANIPULATION WITHIN THE LEFT ATRIUM. DR. NOTICED THAT THE BLOOD PRESSURE WAS ABOUT 40 MM HG LOWER THAN IT HAD BEEN. IT CONTINUED TO FALL AND WAS THEN LESS THAN 100 MM HG SYSTOLIC. DR. CHECKED TO SEE IF THE PATIENT HAD RECEIVED ANY ADDITIONAL SEDATION AND SHE HAD NOT. DR. COULD NOT GET A GOOD VIEW OF THE CARDIAC SILHOUETTE BECAUSE OF THE MAGNETS, WHICH WERE THEN REMOVED. BY THIS TIME THE PATIENT'S BLOOD PRESSURE HAD FALLEN MORE. CURIOUSLY, HER HEART RATE WAS NOT ELEVATED AT ALL (70-80/MIN). RESPIRATIONS BECAME MORE DIFFICULT AND DR. GOT A QUICK BESIDE ECHOCARDIOGRAM THAT CONFIRMED THE PRESENCE OF A LARGE PERICARDIAL EFFUSION. HE THEN PERFORMED PERICARDIOCENTESIS, REMOVING EVENTUALLY ABOUT 500 CC OF BLOOD. AFTER ABOUT 150 CC, HER HEMODYNAMICS IMPROVED DRAMATICALLY. THEY STOPPED INFUSING AND REVERSED THE HEPARIN, LEFT A CATHETER DRAIN IN PLACE, AND WATCHED HER ANOTHER COUPLE OF HOURS IN THE LAB GETTING INTERMITTENT ECHOCARDIOGRAMS SHOWING NO REACCUMULATION. SHE STAYED A COUPLE OF DAYS IN THE HOSPITAL WHERE SHE MADE AN UNEVENTFUL RECOVERY. THE DRAIN WAS REMOVED OF THE FOLLOWING MORNING AFTER ECHOCARDIOGRAM SHOWED NO RESIDUAL EFFUSION. SHE WAS DONE WELL SINCE THEN. DR. ASSESSMENT IS THAT THE SHEATH ITSELF WAS ADVANCED TOO FAR THE SECOND TIME AND CAUSED THE PERFORATION IN THE AREA HE HAD BEEN ABLATING (SOFTER, LESS RESISTANT TO PERFORATION), SINCE THE STEREOTAXIS (BWI) ELECTRODE WAS NOT EVEN IN THE BODY WHEN THE PROBLEM OCCURRED. WHEN THE ELECTRODE WAS WITHDRAWN THE SECOND TIME, IMMEDIATELY PRIOR TO THE FALL IN BLOOD PRESSURE, THERE WAS NO CHAR ON THE ELECTRODE AND IT WAS EASILY REMOVED (NOT ADHERENT TO THE LEFT ATRIAL WALL). THE RAPIDITY WITH WHICH BP FELL SUGGESTS THIS HAD NOT BEEN GOING ON FOR MORE THAN A COUPLE OF MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIOBE MAGNETIC NAVIGATION SYSTEM STEERABLE CATHETER CONTROL SYSTEM DXX STEREOTAXIS, INC. 001-006000-1 0119

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| L| R DIAG SHEATH| BIOSENSE WEBSTER| NAVISTAR RMT CATHETER