BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER

    MDR report key: 6085669 · Received November 8, 2016

    Report

    Report Number
    2015691-2016-03296
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    July 26, 2016
    Report Date
    October 18, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE 746F8 CATHETER WITH AN ATTACHED MONOJECT 1.5CC LIMITED VOLUME SYRINGE WITHOUT THE PACKAGING OR PRESSURE MONITORING DEVICE FOR EXAMINATION. THE REPORTED EVENT OF PRESSURE ISSUES WAS NOT CONFIRMED. NO FAULT MESSAGES SHOWED UP ON THE LABORATORY VIGILANCE II MONITOR WHEN THE CATHETER WAS CONNECTED. THE CATHETER PASSED IN-VITRO CALIBRATION ON THE VIGILANCE II MONITOR. THE THERMISTOR WAS FOUND TO READ 37.0 C WHEN SUBMERGED INTO A 37.0 C WATER BATH. THERMISTOR TEMPERATURE READING ACCURACY IS +/- 0.3C PER THE VIGILANCE MANUAL. THE CATHETER RAN CCO IN 37.0 C WATER BATH ON THE VIGILANCE II MONITOR FOR 5 MINUTES WITH NO ERROR. THERMISTOR AND THERMAL FILAMENT CIRCUITS WERE CONTINUOUS, THERE WERE NO OPEN OR INTERMITTENT CONDITIONS. THE EEPROM DATA WAS FOUND TO BE NORMAL, BOTH THE STORED DATA AND THE COMPUTED DATA MATCHED. RESISTANCE VALUE OF THERMAL FILAMENT CIRCUIT WAS MEASURED AT 36.84 OHMS WHICH WAS IN SPECIFICATION. THE OPTIC CONNECTOR WAS OPENED AND THE FIBER COIL WAS NOT DAMAGED. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THE BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR MORE THAN 5 MINUTES WITHOUT LEAKAGE. THE CATHETER BODY WAS FREE OF KINKS OR INDENTATIONS AND THE RETURNED SYRINGE FUNCTIONED NORMAL. INVASIVE PROCEDURES INVOLVE SOME PATIENT RISKS. ALTHOUGH SERIOUS COMPLICATIONS ARE RELATIVELY UNCOMMON, THE PHYSICIAN IS ADVISED, BEFORE DECIDING TO INSERT OR USE THE CATHETER, TO CONSIDER THE POTENTIAL BENEFITS IN RELATION TO THE POSSIBLE COMPLICATIONS. THE TECHNIQUES FOR INSERTION, METHODS OF USING THE CATHETER TO OBTAIN PATIENT DATA INFORMATION, AND THE OCCURRENCE OF COMPLICATIONS IS WELL DESCRIBED IN THE LITERATURE. WITH ANY HEMODYNAMIC MONITORING, PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY. PRESSURE TUBING THAT IS USED WITH SWAN GANZ CATHETERS CAN ALSO BE A CONTRIBUTING FACTOR TO INACCURATE VALUES. IN REGARDS TO THE PRESSURE TUBING USED WITH SWAN GANZ CATHETERS, IT SHOULD BE NOTED THAT POOR DYNAMIC RESPONSE CAN BE CAUSED BY AIR BUBBLES, CLOTTING, EXCESSIVE LENGTHS OF TUBING, EXCESSIVELY COMPLIANT PRESSURE TUBING, SMALL BORE TUBING, LOOSE CONNECTIONS, OR LEAKS. PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENT¿S CLINICAL MANIFESTATIONS. 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE COMPLETION OF THE PRODUCT EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WITH THE EVALUATION RESULTS WHEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO WAVEFORM WAS SEEN ON THE MONITOR. THE PRESSURE WENT HIGH WHEN OUTSIDE OF THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS LATER INDICATED BY THE CUSTOMER THAT NO ADDITIONAL TREATMENT WAS GIVEN DUE TO THE HIGH VALUES. THE HIGH VALUES WERE NOTED DURING PLACEMENT OF CATHETERS OR BEFORE AND NEW CATHETERS WERE PLACED. HIGH VALUES BEEN AROUND 30. NO ALARMS WERE SEEN ON THE MONITOR DUE TO THE VALUES. INQUIRED OF PATIENT DEMOGRAPHICS. UNABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737210 SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES 746F8 60409169

    Patients

    Seq Age Sex Outcome Treatment
    1