BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWAN-GANZ CATHETER

    MDR report key: 23758998 · Received December 9, 2025

    Report

    Report Number
    2015691-2025-09872
    Event Type
    Death
    Date Received
    December 9, 2025
    Date of Event
    October 22, 2025
    Report Date
    January 16, 2026
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DYG
    UDI-DI
    00690103146998
    PMA / PMN Number
    K233824
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION H6 (TYPE OF INVESTIGATION), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). AS REPORTED, IN A 69 YEARS OLD WOMAN WITH A LVAD (LEFT VENTRICULAR ASSIST DEVICE) SINCE 2014 TRANSFERRED FROM EXTERNAL REA (RESUSCITATION) WITH SUSPECTED INFECTION IN THE CONTEXT OF BRONCHOSPASM WITH VERY HIGH VENTILATION PRESSURES WITHOUT TENSION PNEUMOTHORAX AND WITH RV (RIGHT VENTRICLE) FAILURE AND SUBSEQUENT SUCTIONING OF THE LVAD VS LVAD INFLOW THROMBOSIS, THIS SWAN GANZ CATHETER, INSERTED IN THE INTERNAL JUGULAR VEIN ABOUT 16 H BEFORE, WAS REPOSITIONED BECAUSE IT HAD STOPPED PROVIDING VALUES AND THEN A FULMINANT ARTERIAL-PULMONARY BLEEDING OCCURRED. PATIENT WAS PUT ON VA-ECMO (VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION) AND MASSIVE TRANSFUSION WAS DONE. THE PATIENT DIED AROUND SIX HOURS LATER. USER COMMUNICATED THAT IT WAS NOT POSSIBLE TO DETERMINE IF THE EVENT WAS RELATED OR NOT TO THE DEVICE. THE DEVICE WAS NOT RETAINED FOR EVALUATION. USER REPORT DOES NOT CONTAIN A CLEAR ALLEGATION OF RELATIONSHIP BETWEEN OUR DEVICE AND THE PATIENT DEATH. ALSO, THE DEVICE WAS DISCARDED AND NOT AVAILABLE FOR FURTHER INVESTIGATION. BASED ON THAT, FURTHER INVESTIGATION COULD NOT BE COMPLETED AND NO ROOT CAUSE COLD BE IDENTIFIED. THE MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE; ALL PROCESS PARAMETERS WERE MET AND INSPECTIONS PASSED SUCCESSFULLY. THE IFU STATES: CATHETER INSERTION: CONFIRM FINAL CATHETER TIP POSITION WITH CHEST X-RAY. NOTE: AFTER DEFLATION, THE CATHETER TIP MAY TEND TO RECOIL TOWARDS THE PULMONIC VALVE AND SLIP BACK INTO THE RIGHT VENTRICLE, REQUIRING THAT THE CATHETER BE REPOSITIONED. MAINTENANCE AND USE IN SITU: CATHETER TIP MIGRATION ANTICIPATE SPONTANEOUS CATHETER TIP MIGRATION TOWARDS PERIPHERY OF PULMONARY BED. CONTINUOUSLY MONITOR DISTAL LUMEN PRESSURE TO VERIFY TIP POSITION. IF WEDGE TRACING IS OBSERVED WHEN BALLOON IS DEFLATED, PULL CATHETER BACK. DAMAGE MAY BE CAUSED BY PROLONGED OCCLUSION OR OVER DISTENSION OF VESSEL UPON RE-INFLATION OF THE BALLOON. SPONTANEOUS CATHETER TIP MIGRATION TOWARDS THE PERIPHERY OF THE LUNG OCCURS DURING CARDIOPULMONARY BYPASS. PARTIAL CATHETER WITHDRAWAL (3 TO 5 CM) JUST BEFORE BYPASS SHOULD BE CONSIDERED, AS IT MAY HELP REDUCE DISTAL MIGRATION AND PREVENT PERMANENT CATHETER WEDGING POST BYPASS. AFTER TERMINATION OF BYPASS, THE CATHETER MAY REQUIRE REPOSITIONING. CHECK THE DISTAL PULMONARY ARTERY TRACING BEFORE INFLATING THE BALLOON. AND SPONTANEOUS TIP WEDGING: THE CATHETER MAY MIGRATE INTO THE DISTAL PULMONARY ARTERY AND SPONTANEOUS TIP WEDGING MAY OCCUR. TO AVOID THIS COMPLICATION, PULMONARY ARTERY PRESSURE SHOULD BE MONITORED CONTINUOUSLY WITH A PRESSURE TRANSDUCER AND DISPLAY MONITOR. FORWARD ADVANCEMENT SHOULD NEVER BE FORCED IF RESISTANCE IS ENCOUNTERED THE IFU HAS BEEN REVIEWED, AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED THROUGH TRENDING ON A MONTHLY BASIS AND CONTINUE TO BE MONITORED FOR ANY UNFAVORABLE TRENDS AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    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. IT WAS FURTHER INFORMED THAT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED AT HOSPITAL. WITHOUT RETURN OF THE PRODUCT, EDWARDS IS UNABLE TO PERFORM A COMPLETE INVESTIGATION OF THE REPORTED EVENT. IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO IT, AND THEREFORE NO ACTIONS COULD BE PLANNED.

    Description of Event or Problem · 0

    AS REPORTED, IN A 69 YEARS OLD WOMAN WITH A LVAD (LEFT VENTRICULAR ASSIST DEVICE) SINCE 2014 TRANSFERRED FROM EXTERNAL REA (RESUSCITATION) WITH SUSPECTED INFECTION IN THE CONTEXT OF BRONCHOSPASM WITH VERY HIGH VENTILATION PRESSURES WITHOUT TENSION PNEUMOTHORAX AND WITH RV (RIGHT VENTRICLE) FAILURE AND SUBSEQUENT SUCTIONING OF THE LVAD VS LVAD INFLOW THROMBOSIS, THIS SWAN GANZ CATHETER, INSERTED IN THE INTERNAL JUGULAR VEIN ABOUT 16H BEFORE, WAS REPOSITIONED BECAUSE IT HAD STOPPED PROVIDING VALUES AND THEN A FULMINANT ARTERIAL-PULMONARY BLEEDING OCCURRED. PATIENT WAS PUT ON VA-ECMO (VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION) AND MASSIVE TRANSFUSION WAS DONE. THE PATIENT DIED AROUND SIX HOURS LATER. USER COMMUNICATED THAT IT WAS NOT POSSIBLE TO DETERMINE IF THE EVENT WAS RELATED OR NOT TO THE DEVICE, BUT IT WAS NOTIFIED DUE TO TWO DEATHS (COMPLAINTS (B)(4) AND (B)(4)) WITHIN 3 CALENDAR DAYS IN THE INTENSIVE CARE UNIT WITH THE SAME TYPE OF SWAN-GANZ CATHETER. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2733010 SWAN-GANZ CATHETER CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES DR 774F75 66844441 00690103146998

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death