BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER AMC THROMBOSHIELD

    MDR report key: 3073563 · Received April 23, 2013

    Report

    Report Number
    2015691-2013-19890
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXG
    PMA / PMN Number
    K040287
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE HOSPITAL. THE EVENT WAS PRESENTED IN THE ARTICLE AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE OCCURRENCE DATE IS UNKNOWN. PERFORATION OF THE PULMONARY ARTERY IS LISTED AS A POTENTIAL COMPLICATION IN THE PRODUCT IFU: FACTORS ASSOCIATED WITH THE DEVELOPMENT OF FATAL PULMONARY ARTERY RUPTURE DURING THE USE OF FLOW-DIRECTED BALLOON-TIPPED CATHETERS ARE PULMONARY HYPERTENSION, ADVANCED AGE, CARDIAC SURGERY WITH HYPOTHERMIA AND ANTICOAGULATION, DISTAL CATHETER TIP MIGRATION, ARTERIOVENOUS FISTULA FORMATION AND OTHER VASCULAR TRAUMAS. THE IFU FURTHER NOTES: 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. NO DEVICE MALFUNCTION IS INDICTED IN THE REPORT AND THE EVENTS REPORTED ARE INCLUDED IN THE LABELING. NO ACTIONS ARE NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE (B)(6) JOURNAL OF ANESTHESIOLOGY, VOL. 62, NO. 2, 2013 (BRIEF REPORT, PAGE 202 TO 203) THAT AFTER MITRAL VALVE REPLACEMENT A PATIENT DEVELOPED MASSIVE TRACHEAL BLEEDING DURING WEANING FROM THE CARDIOPULMONARY BYPASS. TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED THE AIR BELL IN THE RIGHT PULMONARY ARTERY SYNCHRONIZED WITH VENTILATION. WE SPECULATED PULMONARY ARTERY INJURY AND PERFORMED PULMONARY ARTERY ANGIOGRAPHY; HOWEVER, IT COULD NOT CLARIFY THE BLEEDING POINT. SURGICAL APPROACH FOUND THE AIR LEAK FROM THE ERASURE OF THE BRONCHUS INTERMEDIUS AND THE LOBECTOMY LED TO LIFESAVING. A PULMONARY ARTERY INJURY CAUSED BY PAC IS VERY RARE BUT LIFE-THREATENING. IN THIS CASE, THE PATIENT HAD SOME RISK FACTORS (I.E. 60 YEARS OR OLDER, FEMALE, SHORT STATURE, AND MITRAL VALVE DISEASE); HOWEVER, IT WAS HARD TO PREDICT THE PULMONARY INJURY FROM THESE FACTORS. AFTER ANESTHESIA INDUCTION, PAC AND CENTRAL VENOUS CATHETER WERE INSERTED FROM THE RIGHT INTERNAL JUGULAR VEIN. AT THE TIME THE PAC CATHETER WAS FIXED AT 50CM FROM THE ENTRANCE OF THE INTRODUCER SINCE THE CATHETER DID NOT WEDGE EVEN THOUGH THE CATHETER WAS INSERTED THIS DEEP. THEN THE CATHETER WAS PULLED BACK TO 40CM WHEN STARTING THE CARDIOPULMONARY BYPASS CONSIDERING THAT THE CATHETER MOVES FORWARD BY THE BLOOD REMOVAL. AFTER THE LOBECTOMY, THE TRACHEAL BLEEDING STOPPED, HOWEVER PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS REQUIRED. ONE-LUNG VENTILATION WAS TAKEN FOR 2 DAYS AFTER SURGERY. AFTER THAT, THE PATIENT'S CARDIOPULMONARY FUNCTION GRADUALLY RECOVERED AND PCPS WAS WEANED 5 DAYS AFTER THE SURGERY, VENTILATOR WAS WEANED 75 DAYS AFTER THE SURGERY AND THE PATIENT LEFT THE HOSPITAL ON FOOT 144 DAYS AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173481 SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER AMC THROMBOSHIELD SWAN-GANZ CATHETER DXG EDWARDS LIFESCIENCES, PR 774HF75J

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR