BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2172079 · Received July 22, 2011

    Report

    Report Number
    2015691-2011-15908
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RECEIVED WITH THE CONTAMINATION SHIELD ATTACHED TO THE CATHETER, THE PROXIMAL END WAS APPROXIMATELY 89CM FROM THE TIP. AN EDWARDS PRESSURE TRANSDUCER AND ASSOCIATED TUBING WERE ATTACHED TO PA DISTAL HUB. TESTING WAS DONE WITH THE RETURNED DPT TUBING CONNECTED TO THE HUB. THE CAL-CUP WAS NOT RETURNED, TESTING WAS DONE USING A LAB CAL-CUP. UPON REMOVAL OF THE CONTAMINATION SHIELD, THE CATHETER BODY APPEARED COLLAPSED APPROXIMATELY 89CM FROM THE TIP. THE CATHETER PASSED IN-VITRO CALIBRATION ON BOTH VIGILANCE I AND II MONITORS. THE CATHETER ALSO PASSED TRANSMISSION AND CROSS-TALK TESTING. THE CATHETER RAN CCO ON VIGILANCE I AND VIGILANCE II MONITORS FOR 5 MINUTES WITH NO ERROR MESSAGES. NO VISIBLE INCONSISTENCIES WERE OBSERVED ON EEPROM DATA. THE THERMISTOR AND THERMAL FILAMENT CIRCUIT WERE CONTINUOUS. THE THERMISTOR READ 37.1 C WHEN SUBMERGED IN A 37.0 C WATER BATH. THERE WERE NO OPEN OR INTERMITTENT CONDITIONS. BOTH THERMISTOR AND THERMAL FILAMENT CONNECTORS WERE OPENED WITH NO VISIBLE INCONSISTENCIES. THE BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. A 10CC SYRINGE WAS CONNECTED TO EACH OF THE LUMENS BEING TESTED. EACH ASSOCIATED PORT WAS COVERED WITH A FINGERTIP, ENTIRE CATHETER WAS IMMERSED IN WATER AND PRESSURIZED WITH AIR BY COMPRESSING THE SYRINGE PLUNGER. ALL THROUGH LUMENS WERE PATENT WITHOUT LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED FROM THE OPTICAL MODULE CONNECTOR OR RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. THE PA DISTAL HUB AND PROX INJECTATE HUB APPEARED TO HAVE BEEN DAMAGED FROM CLAMPS. CARDIAC OUTPUT TESTING WAS DONE ON VIGILANCE I AND II MONITORS. DURING TESTING OF THE RETURNED PRESSURE TRANSDUCER, THE DPT ZEROED AND SENSED PRESSURE; NO FAILURES WERE NOTED. THE COMPLAINT COULD NOT BE CONFIRMED DURING TESTING; NO PRODUCT PROBLEMS WERE IDENTIFIED. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CCO AND SVO2 MEASUREMENTS WERE "BAD" IMMEDIATELY AFTER INSERTION BY THE CARDIOLOGIST. ENGINEERING DID NOT PROVIDE DIRECT TROUBLESHOOTING SUPPORT. FOLLOW UP INDICATED THAT WRONG SVO2 AND CCO NUMBERS WERE "RIDICULOUS", THE NUMBERS LESS THAN 4 WERE OBSERVED ON THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD CONTINOUS CARDIAC OUPTUT CATHETER DYG EDWARDS LIFESCIENCES, PR 746HF8

    Patients

    Seq Age Sex Outcome Treatment
    1