BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWAN-GANZ VIP+ TRI-LUMEN INFUSION THERMODILUTION CATHETE

    MDR report key: 6089736 · Received November 9, 2016

    Report

    Report Number
    2015691-2016-03313
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 21, 2016
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    PMA / PMN Number
    K810352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT RETURN OF THE UNIT IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE IFU FOR THIS PRODUCT STATES ¿KEEP PRESSURE MONITORING LUMENS PATENT BY INTERMITTENT FLUSH OR CONTINUOUS SLOW INFUSION WITH HEPARINIZED SALINE SOLUTION.¿ POTENTIAL RISKS ASSOCIATED WITH THE USE OF SWAN-GANZ CATHETERS INCLUDE THROMBUS FORMATION, PLAQUE DISLODGEMENT, AND EMBOLIZATION THAT MAY RESULT IN MYOCARDIAL INFARCTION, STROKE, DISTAL PERIPHERAL OCCLUSION, AND/OR DEATH. THE DURATION OF CATHETERIZATION SHOULD BE THE MINIMUM REQUIRED BY THE PATIENT¿S CLINICAL STATE SINCE THE RISK OF THROMBOEMBOLIC AND INFECTIOUS COMPLICATIONS INCREASES WITH TIME. THE INCIDENCE OF COMPLICATIONS INCREASES SIGNIFICANTLY WITH INDWELLING PERIODS LONGER THAN 72 HOURS. 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.

    Additional Manufacturer Narrative · 1

    PLEASE SEE RELATED MEDWATCH NUMBERS: 2015691-2016-03261, 2015691-2016-03314, 2015691-2016-03316, AND 2015691-2016-03319.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SINCE MAKING THE CHANGE TO NON-HEPARIN COATED CATHETERS THEY HAVE SEEN AN INCREASE IN THE AMOUNT OF BLOOD CLOTTING ON THE SWAN GANZ CATHETERS. IN THE PAST THREE WEEKS, THERE HAVE BEEN 5 CASES OF THROMBUS FOUND ON THE SWAN GANZ CATHETERS. ECHOCARDIOGRAMS DEMONSTRATING 1-2CM THROMBUS ON THE CATHETERS WERE NOTED. IT WAS STATED BY THE CUSTOMER THAT THESE EVENTS ARE OCCURRING PRIMARILY DURING OPEN HEART SURGERY CASES, PRIOR TO THE PATIENT BEING HEPARINIZED. CLOTS ARE FORMING NEAR THE PROXIMAL INFUSION PORT, NEAR THE SVC/RIGHT ATRIAL JUNCTION. THE CUSTOMER REPORTED THAT THEY HAVE NOT CHANGED PRACTICE WITH REGARD TO USE OF THE CATHETER OR PERSONNEL. TO DATE THERE HAVE BEEN NO NEGATIVE PATIENT SAFETY EVENTS, HOWEVER, SOME CASES HAVE BEEN POSTPONED DUE TO THE PRESENCE OF CLOTS. COMPLAINTS WERE OPENED AND MDR'S WERE FILED FOR EACH OF THE 5 CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742097 SWAN-GANZ VIP+ TRI-LUMEN INFUSION THERMODILUTION CATHETE CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 834F75 60486724 POSSIBLE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other