BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER

    MDR report key: 3013204 · Received March 20, 2013

    Report

    Report Number
    2015691-2013-19598
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K810352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE KINK PREVIOUSLY OBSERVED MAY HAVE CONTRIBUTED TO THE ABNORMAL WAVEFORM AND INACCURATE PRESSURES ORIGINALLY REPORTED. UPON REMOVAL OF CONTAMINATION SHIELD, A KINK WAS FOUND AT APPROXIMATELY THE 107 CM AREA. SLIGHT INDENTATIONS WERE ALSO OBSERVED APPROXIMATELY AT THE 95 CM AREA AND 46 CM AREA. DAMAGE TO THE CATHETER BODY MAY AFFECT THE ACCURACY OF PRESSURE MONITORED. THE CATHETER WAS CONNECTED TO AN EDWARDS PRESSURE MONITORING KIT, AND SENSED PRESSURE ACCURATELY. WHEN OBSTRUCTING FLOW AT THE KINKED AREA ON THE CATHETER, PRESSURE DROPPED ON THE MONITOR. PER IFU, "OVERTIGHTENING THE TUOHY-BORST ADAPTERS OF THE CONTAMINATION SHIELD MAY IMPAIR CATHETER FUNCTION." THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. THE BALLOON DEFLATED IN 2 SECONDS WITHOUT THE SYRINGE ATTACHED. THE BALLOON FAILED TO DEFLATE FULLY WITH RETURNED SYRINGE ATTACHED. PER IFU, 'PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE FROM THE GATE VALVE.' ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED FROM RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. NO MANUFACTURING NON-CONFORMANCES WERE NOTED DURING THE PRODUCT EVALUATION. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RECEIVED WITH AN ATTACHED MONOJECT 1.5CC LIMITED VOLUME SYRINGE AND AN ATTACHED CONTAMINATION SHIELD. BALLOON TESTING WAS PERFORMED WITH THE RETURNED SYRINGE. THE BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. THE BALLOON DEFLATED WITHIN 2 SECONDS WITHOUT A SYRINGE ATTACHED, WHICH IS WITHIN THE SPECIFICATION OF 4 SECONDS. THE BALLOON FAILED TO DEFLATE FULLY WITH RETURNED SYRINGE ATTACHED. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THERE WAS NO VISIBLE DAMAGE OBSERVED FROM THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. UPON REMOVAL OF CONTAMINATION SHIELD, A KINK WAS FOUND AT APPROXIMATELY THE 107 CM AREA. SLIGHT INDENTATIONS WERE ALSO OBSERVED APPROXIMATELY AT THE 95 CM AREA AND 46 CM AREA. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. THE REPORTS OF "NOT GETTING APPROPRIATE READINGS OR WAVEFORMS" AND BALLOON DEFLATION ISSUE WERE NOT CONFIRMED. ALTHOUGH THE REPORTED COMPLAINT CANNOT BE CONCLUSIVELY DETERMINED, HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AS PER SWAN-GANZ IFU, 'PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE FROM THE GATE VALVE.' WITHOUT THE RETURN OF THE PRESSURE MONITORING UNIT, CUSTOMER REPORT OF PRESSURE ISSUE COULD NOT BE CONFIRMED; IT APPEARS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE PRESSURE ISSUE. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE NOTED THAT THE CATHETER WAS NOT GETTING APPROPRIATE READINGS OR WAVEFORMS. THE PHYSICIAN WAS CALLED IN AND ATTEMPTED TO REFLOAT THE CATHETER INTO POSITION BUT WAS NOT ABLE TO DO SO. THE PHYSICIAN ORDERED THE LINE TO BE DISCHARGED. WHEN THE BALLOON WAS DEFLATED, IT APPEARED THAT ALL THE AIR WAS REMOVED, BUT WHEN THE CATHETER WAS PULLED THE BALLOON WAS STILL PARTIALLY INFLATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. FOLLOW UP INDICATED THAT THE MEASUREMENTS WERE NOT APPROPRIATE TO WHAT WAS EXPECTED. NUMBERS WERE NOT EVEN CLOSE TO WHAT SHOULD HAVE BEEN 'NORMAL.' THE PHYSICIAN WAS NOTIFIED AND ATTEMPTED TO REFLOAT THE CATHETER BACK INTO POSITION THREE TIMES. AS HE WAS ADVANCING THE CATHETER THROUGH THE CHAMBERS OF THE HEART, THE WAVEFORM DID NOT CHANGE AS IT IS EXPECTED WHEN TRAVERSING THIS AREA. THE MONITOR BEING USED WAS THE STANDARD MONITOR AND ICU CABLE. AN EDWARDS PRESSURE MONITORING DEVICE WAS NOT BEING USED. THE WAVEFORM WAS NOT NORMAL IN SHAPE, RN DESCRIBES THE WAVEFORM AS 'SQUATTED, NOT AS HIGH AND ROUNDED AS EXPECTED.' THE BALLOON WAS DEFLATED AND SYRINGE THEN REMOVED. CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116792 SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 831F75

    Patients

    Seq Age Sex Outcome Treatment
    1