BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWAN-GANZ CATHETER

    MDR report key: 23725942 · Received December 5, 2025

    Report

    Report Number
    2015691-2025-09779
    Event Type
    Death
    Date Received
    December 5, 2025
    Date of Event
    October 25, 2025
    Report Date
    January 15, 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, TEN MINUTES AFTER MEASURING THE PULMONARY WEDGE PRESSURE WITH THIS SWAN GANZ CATHETER PLACED IN A PATIENT SUFFERING A THERAPY-REFRACTORY SHOCK OF UNCLEAR ORIGIN DURING THE POSTOPERATIVE COURSE FOLLOWING 3-VESSEL CORONARY ARTERY BYPASS SURGERY, THE PATIENT SUFFERED ENDOBRONCHIAL HEMORRHAGE. PATIENT GOT HEMODYNAMIC INSTABLE AND VA-ECMO (VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION) WAS INITIATED, BUT DESPITE ONGOING THERAPY WITH PRESSURE INFUSION, HIGH-DOSE VASOPRESSORS AND INOTROPES, CARDIAC ARREST OCCURRED AND PATIENT DIED. 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 COULD BE IDENTIFIED. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE LOT INVOLVED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE. ALL PROCESS PARAMETERS WERE MET AND INSPECTIONS PASSED SUCCESSFULLY. THE IFU STATES: 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

    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. 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.

    Description of Event or Problem · 0

    AS REPORTED, DURING THE POSTOPERATIVE COURSE FOLLOWING 3-VESSEL CORONARY ARTERY BYPASS SURGERY, A SWAN-GANZ CATHETER WAS PLACED AT APPROXIMATELY 1:30 AM AFTER A PATIENT THERAPY-REFRACTORY SHOCK OF UNCLEAR ORIGIN. TEN MINUTES AFTER MEASURING THE PULMONARY WEDGE PRESSURE, THE PATIENT DEVELOPED AN ENDOBRONCHIAL HEMORRHAGE, CONFIRMED BY BRONCHOSCOPY AS BLEEDING FROM THE RIGHT LOWER LOBE OR SEGMENT 6 OF THE RIGHT LUNG. THIS LED TO AN INCREASING HEMODYNAMIC INSTABILITY AND BLOOD LOSS VIA BOTH INDWELLING PLEURAL DRAINS. AT AROUND 1:50 AM, THE DECISION WAS MADE TO INITIATE VA-ECMO (VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION), BUT DESPITE ONGOING THERAPY WITH PRESSURE INFUSION, HIGH-DOSE VASOPRESSORS AND INOTROPES, CARDIAC ARREST OCCURRED AT 1.55 AM, AND RESUSCITATION WAS INITIATED. VA-ECMO WAS FINALLY IMPLANTED AT APPROX. 2:30 AM. DUE TO CONTINUED MASSIVE TRANSFUSION REQUIREMENTS, A BEDSIDE THORACOTOMY WAS PERFORMED, REVEALING A SEVERE BLEEDING FROM MULTIPLE SITES AT THE LUNG HILUM, WHICH COULD NOT BE SURGICALLY CONTROLLED. THE PATIENT DIED AT 03:56 AM. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857198 SWAN-GANZ CATHETER CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES DR 774F75 66844441 00690103146998

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death