BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME

    MDR report key: 3656060 · Received March 3, 2014

    Report

    Report Number
    2015691-2014-00500
    Event Type
    Injury
    Date Received
    March 3, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K043103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER THE COMPLIANT COULD NOT BE CONFIRMED WITHOUT THE COMPLETION OF THE PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE DEVICE WAS PERFORMED AND NO PHYSICAL DAMAGE WAS OBSERVED. THE MONITOR PERFORMED AS EXPECTED IN ALL TEST CONDITIONS. FUNCTIONAL TESTING OF THE SYSTEM WAS CONDUCTED IN VARIOUS FLOW CONDITIONS TO CONFIRM FUNCTIONALITY OF THE THERMAL ELEMENT CONTROLS AND SAFETY SYSTEMS. THE SYSTEM WAS AGGRESSIVELY CHALLENGED BY REDUCING FLOW AROUND THE CATHETER WHILE IN CCO MODE AND THE SYSTEM PERFORMED AS DESIGNED IN ALL TEST CONDITIONS. ALSO RETURNED WITH THE MONITOR WERE THE SUSPECT CATHETER AND THREE CABLES. AT THE TIME THE EVENT WAS REPORTED THE CUSTOMER WAS UNSURE OF WHICH CABLE WAS USED IN THE CASE. THEREFORE, THE THREE (3) CABLES MAINTAINED IN THE OR SUITE WERE RETURNED TO EDWARDS FOR EVALUATION (SEE RELATED COMPLAINTS: (B)(4)). ALL CABLES WERE EVALUATED AT EDWARDS INDEPENDENT OF THE RETURNED MONITOR TO VERIFY FUNCTIONALITY. ALL WERE FOUND TO BE NON-FUNCTIONING. VISUAL INSPECTION REVEALED A BROKEN CABLE CONNECTOR OVER-MOLD ON ONE CABLE. DURING FUNCTIONAL TESTING THE MONITOR DISPLAYED ¿FAIL ¿ REPLACE CABLE¿ ON ALL THREE CABLES. TWO OUT OF THE THREE CABLES WERE PAST THEIR SHELF LIFE AND CONTINUITY TESTING CONFIRMED AN OPEN WIRE CONNECTION ON ALL THREE CABLES. THE INVESTIGATION SUPPORTS THAT THE THREE RETURNED CABLES COULD NOT HAVE BEEN USED DURING THIS PROCEDURE, AND THEREFORE CANNOT BE CONSIDERED A CONTRIBUTOR TO THIS EVENT. FAILURES OF THIS NATURE ARE CONSISTENT WITH IMPROPER HANDLING AND/OR STORAGE BY THE CUSTOMER AND THERE IS NO INDICATION OR EVIDENCE TO SUGGEST THAT THEY ARE THE RESULT OF ANY MANUFACTURING DEFECT. EVALUATION OF THE RELATED COMPLAINT (B)(4) FOR THE SWAN GANZ CATHETER WAS PERFORMED. THE CATHETER WAS RECEIVED IN THE EVALUATION LAB FOR VISUAL EXAMINATION, PHOTOS AND X-RAY. VISUAL EXAMINATION DID NOT FIND ANY ABNORMALITIES WITH THE CATHETER BODY, THERMAL FILAMENT, EXTENSION TUBES, HUBS OR THERMISTOR AND THERMAL FILAMENT CONNECTORS. THERMAL ELEMENT RESISTANCE VS. TEMPERATURE TEST WAS PERFORMED. THE RESISTANCE OF THE THERMAL ELEMENT OF THE CATHETER AND 5 ADDITIONAL CONTROL UNITS WERE MEASURED IN SPECIFIC FLUID BATH TEMPERATURES. IT WAS CONCLUDED THAT THE RESISTANCE OF THE THERMAL ELEMENT OF THE CATHETER MATCHED THE RESISTANCE THAT WAS INITIALLY PROGRAMMED IN THE CATHETER AS RECORDED IN THE EEPROM VALUES. THERE WERE NO NOTABLE DIFFERENCES BETWEEN THE CATHETER AND THE CONTROL UNITS TESTED. THEREFORE, IT WAS CONCLUDED THAT THE RESISTANCE OF THE THERMAL ELEMENT OF THE CATHETER OPERATED WITHIN EXPECTED PARAMETERS. EDWARD¿S PERSONNEL VISITED THE CLINICAL SITE TO GATHER FURTHER INFORMATION REGARDING THE CASE. THE TIMELINES FROM THE ANESTHESIA RECORD AND VIGILANCE II MACHINE WERE REVIEWED. THE ANESTHESIOLOGIST STATED THAT THERE WERE NO PROBLEMS WITH THE INSERTION OF THE CATHETER AND THAT THE PLACEMENT WAS VERIFIED BY ECHO. HE SPOKE ABOUT THE CATHETER BEING PULLED BACK DURING THE REPAIR OF THE PULMONARY ARTERY AND THE REPOSITIONING AFTER COMPLETION OF THE REPAIR. REGARDING THE INJURY, HE STATED THAT THE INJURY WAS ¿VERY SUPERFICIAL¿ AND THERE WAS LITTLE CONCERN ABOUT IT IN THE OR. HE MENTIONED THAT THE INJURY WAS NOT TRANSMURAL AND WAS NOT NOTED UNTIL THE RIGHT ATRIUM WAS OPENED FOR THE TRICUSPID VALVE REPAIR. HE STATED ¿BELIEVE ME, IF THERE WAS ANYTHING OTHER THAN A SUPERFICIAL INJURY, YOU WOULD HAVE GOTTEN A PHONE CALL IMMEDIATELY.¿ HE CONFIRMED THAT THEY CONTINUED TO USE THE CATHETER WITHOUT INCIDENT UNTIL IT WAS REMOVED ON POST-OPERATIVE DAY #1. THE PATIENT RECOVERED UNEVENTFULLY. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY #6. SEE ADDITIONAL REPORTS: 2015691-2014-00501 (70CC2 CABLE), 2015691-2014-00503 (70CC2 CABLE), 2015691-2014-00502 (70CC2 CABLE), 2015691-2014-00455 (SWAN GANZ CATHETER).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT INCURRED A 3CM LINEAR FULL THICKNESS BURN IN THE RIGHT ATRIUM DURING AN AORTIC ROOT REPLACEMENT AND TRICUSPID VALVE REPAIR. THE BURN WAS ON THE LATERAL ATRIAL WALL ADJACENT TO A THERMAL FILAMENT OF A CCO SWAN GANZ CATHETER. THE SURGEON STATED THAT IT ¿LOOKED LIKE AN ABLATION BURN¿. THE SURGEON STATED THAT SHE WAS ABLE TO ¿EASILY SUTURE REPAIR THE INJURY¿. SHE ALSO STATED THAT THE CCO FEATURE OF THE SWAN GANZ CATHETER WAS TURNED OFF WHEN THE PATIENT WENT ON BYPASS AND WORKED WELL AFTER THE CASE. NO PATIENT COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED ON POD #6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126184 VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES VIG2 VG003340

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention