BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER 24 CM PROXIMAL PORT

    MDR report key: 6153376 · Received December 7, 2016

    Report

    Report Number
    2015691-2016-03597
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 18, 2016
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K810124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    ONE CATHETER WITH ATTACHED BD 1 ML SYRINGE AND TERUMO 10 ML SYRINGE AT THE PROXIMAL INJECTATE HUB WAS RETURNED FOR EVALUATION. NO VISIBLE DAMAGE TO THE CATHETER BODY, BALLOON, OR RETURNED SYRINGE WAS OBSERVED. NO ERROR MESSAGE WAS OBSERVED ON VIGILANCE II MONITOR. THE THERMISTOR WAS SUBMERGED IN A 37.0 C WATER BATH AND READ 37.0 C ON VIGILANCE II MONITOR. THE THERMISTOR CIRCUIT WAS CONTINUOUS AND THERE WERE NO OPEN OR INTERMITTENT CONDITIONS. THE THERMISTOR CONNECTOR WAS OPENED AND NO VISIBLE ABNORMALITIES WERE FOUND. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. BALLOON INFLATION TESTING WAS PERFORMED USING RETURNED SYRINGE WITH 0.8 CC AIR BY HOLDING THE BALLOON UNDER WATER FOR 5 MINUTES. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION AND WITH THE UNAIDED EYES. CUSTOMER REPORT OF CO MEASUREMENT ISSUE COULD NOT BE CONFIRMED DURING THE ANALYSIS, AS THE DEVICE RESPONDED APPROPRIATELY DURING FUNCTIONAL TESTING. THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. IT IS UNKNOWN IF ANY CLINICAL OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDICATED VALUE OF ICO VARIED BETWEEN 3.36 L/MIN, 1.18 L/MIN AND 6.36 L/MIN DURING USE. THE CATHETER WAS REPLACED AND THE PROBLEM WAS SOLVED. THE PATIENT WAS NOT TREATED BASED ON THE INCORRECT VALUES. IT IS UNKNOWN IF AN ERROR MESSAGE WAS OBSERVED OR IF THERE WAS AN OCCLUSION, LEAKAGE OR KINK NOTED IN THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT DEMOGRAPHIC INFORMATION REQUESTED BUT UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804136 SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER 24 CM PROXIMAL PORT SWAN-GANZ CATHETER DYG EDWARDS LIFESCIENCES, PR TS105F5 60378369

    Patients

    Seq Age Sex Outcome Treatment
    1