BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIGILANCE II CCO/SVO2/CEDV MONITOR

    MDR report key: 8135142 · Received December 5, 2018

    Report

    Report Number
    2015691-2018-05098
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    November 13, 2018
    Report Date
    November 13, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K043103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    THE VIGILANCE II MONITOR WAS RETURNED FOR ANALYSIS. THE REPORTED EVENT ¿THE NECROSIS OF THE RIGHT ATRIAL APPENDAGE WAS CONFIRMED WHEN THE VIG2 MONITOR WAS IN THE MEASUREMENT PAUSE MODE¿ COULD NOT BE CONFIRMED DURING THE ANALYSIS AS THE MONITOR RESPONDED APPROPRIATELY DURING FUNCTIONAL TESTING. THE ¿OVER 36 HOURS BURN-IN TEST¿, FATU FINAL TEST AND SAFETY TEST WERE CONCLUDED WITH NO FUNCTIONAL FAULT FOUND. THERE WAS NO PHYSICAL DAMAGE OBSERVED AND NO PART WAS REPLACED. THE MONITOR WILL BE RETURNED TO THE CUSTOMER. THE DEVICE HISTORY SERVICE RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE MONITOR MET ALL SPECIFICATIONS UPON DISTRIBUTION. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME. IN THIS CASE, THE REPORTER STATED THAT THE VIGILANCE II MONITOR WAS IN THE PAUSE MODE DURING THE TIME OF THE OCCURRING INJURY. THE VIGILANCE II OPERATOR¿S MANUAL AND SWAN GANZ IFU STATE THAT CCO MONITORING SHOULD ALWAYS BE DISCONTINUED WHEN BLOOD FLOW AROUND THE THERMAL FILAMENT IS STOPPED. CLINICAL SITUATIONS WHERE CCO MONITORING SHOULD BE DISCONTINUED INCLUDE, BUT ARE NOT LIMITED TO: TIME PERIODS WHEN A PATIENT IS ON CARDIOPULMONARY BYPASS. IN THIS INSTANCE THERE ARE MULTIPLE FACTORS THAT COULD HAVE CONTRIBUTED TO THE EVENT INCLUDING THIN CARDIAC TISSUE, THE POTENTIAL FOR THE CATHETER TO HAVE LAID ON THE THIS TISSUE CAUSING THE CARDIAC INJURY OR HEAT FROM THE CATHETER¿S THERMAL FILAMENT IF THE VIGILANCE II MONITOR WAS NOT PUT IN PAUSE MODE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 1

    THE MONITOR IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE MONITOR A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. THE DEVICE HISTORY SERVICE RECORD REVIEW IS PENDING A CORRECT SERIAL NUMBER AND A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS, IF A SERIAL NUMBER IS OBTAINED. REFERENCE SWAN GANZ CATHETER MDR NUMBER 2015691-2018-05041.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT WITH MITRAL INSUFFICIENCY WAS UNDERGOING MITRAL VALVULOPLASTY WITH AN ADVANCED CCO SWAN GANZ CATHETER IN PLACE. DURING USE OF THE CATHETER IN CONJUNCTION WITH A VIGILANCE II MONITOR, NECROSIS OF THE RIGHT ATRIAL APPENDAGE (RAA) OF THE HEART WAS SUSPECTED BY THE CARDIAC SURGEON. THE PATIENT WAS ON BYPASS. DURING THE OPEN HEART SURGERY, THE THERMAL FILAMENT PART OF THE CATHETER WAS VISUALLY SEEN THROUGH THE THIN TISSUE OF THE RA AREA; THEREFORE, TISSUE NECROSIS OF THE RAA AREA WAS SUSPECTED. THE CUSTOMER SUSPECTED COMPRESSION OF THE CATHETER CONTRIBUTED TO THE TISSUE NECROSIS SINCE THE EVENT WAS CONFIRMED WHEN THE VIGILANCE II MONITOR WAS IN THE MEASUREMENT PAUSE MODE. THE CATHETER WAS POSITIONED IN THE PULMONARY ARTERY WHEN IT WAS CONFIRMED. IT WAS CONSIDERED THAT THE CATHETER TOUCHED THE RAA AREA FOR ABOUT 2 HOURS. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS TRANSFERRED TO THE ICU AFTER SURGERY AND THE CATHETER COULD MEASURE CO IN THE ICU. THE CATHETER WAS REMOVED ON THE FOLLOWING DAY. SUBSEQUENTLY, THERE IS NO HEALTH INJURY REPORTED. THE SURGEON REPORTED THAT IT WAS POSSIBLE THE TISSUE OF THE RAA AREA IS ORIGINALLY THIN, NOT DUE TO THE NECROSIS. THE SURGEON STATED THAT CONSIDERING THAT THE VIGILANCE II MONITOR WAS IN PAUSE MODE, IT IS ASSUMED THERE WAS NO INFLUENCE OF HEATING. HOWEVER, THE VIGILANCE II MONITOR IS BEING SENT FOR EVALUATION TO ASSURE THIS IS THE CASE. THE SEVERITY OF THE INJURY TO THE PATIENT WAS DETERMINED BY THE DOCTOR TO BE ¿NOT SERIOUS¿ AND IT IS LESS LIKELY THAT THE EDWARDS DEVICE CONTRIBUTED TO THE EVENT PER THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972393 VIGILANCE II CCO/SVO2/CEDV MONITOR VIG II DXG EDWARDS LIFESCIENCES VIG2

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| O