BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER

    MDR report key: 6085666 · Received November 8, 2016

    Report

    Report Number
    2015691-2016-03295
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    June 24, 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 A MONOJECT LIMITED VOLUME SYRINGE FOR EXAMINATION. NO PRESSURE MONITORING DEVICE WAS RETURNED. THE REPORTED EVENT OF "HIGH VALUES" WAS NOT CONFIRMED. WHEN CONNECTED TO THE VIGILANCE MONITOR THE MONITOR GAVE ¿CHECK THERMAL FILAMENT CONNECTION¿ ERROR MESSAGE. THE THERMAL FILAMENT CIRCUIT WAS FOUND TO HAVE AN INTERMITTENT OPEN CONDITION BETWEEN THE LEAD WIRES AND THE THERMAL FILAMENT WELDS DURING CONTINUITY TESTING. THERMISTOR CIRCUIT WAS CONTINUOUS. THE THERMISTOR WAS SUBMERGED IN A 37.0C WATER BATH AND READ 37.0C ON THE VIGILANCE II MONITOR. THERMISTOR TEMPERATURE READING ACCURACY IS +/- 0.3C PER THE VIGILANCE MANUAL. RESISTANCE VALUE OF THERMAL FILAMENT CIRCUIT COULD NOT BE OBTAINED DUE TO THE INTERMITTENT CONDITION. THE CATHETER PASSED IN-VITRO CALIBRATION ON THE VIGILANCE II MONITOR. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY OR THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. ALTHOUGH THE REPORTED EVENT WAS NOT CONFIRMED, AN INVESTIGATION HAS BEEN INITIATED FOR THE INTERMITTENT CONDITION. 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.

    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 THE PA & CVP PRESSURES DID NOT GIVE A WAVE FORM. 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
    737303 SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES 746F8 60209736

    Patients

    Seq Age Sex Outcome Treatment
    1