BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWAN-GANZ HI-SHORE TRUE SIZE THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2160863 · Received July 13, 2011

    Report

    Report Number
    2015691-2011-15858
    Event Type
    Death
    Date Received
    July 13, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 14, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K812563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION BUT IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    RECEIVED ONE (B)(4) CATHETER, MODEL NO. 141HF7 WITH THE CONTAMINATION SHIELD ATTACHED TO CATHETER; THE PROXIMAL END WAS APPROXIMATELY 75CM FROM THE TIP. UPON REMOVAL OF THE CONTAMINATION SHIELD, A SLIGHT INDENTATION WAS OBSERVED APPROXIMATELY 74CM FROM THE TIP. BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND REMAINED INFLATED FOR MORE THAN 5 MINUTES WITHOUT ANY LEAKAGE. ALL THROUGH LUMENS WERE TESTED FOR PATENCY AND LEAKAGE AND THERE WAS NO LEAKAGE OR OCCLUSION IDENTIFIED. THE (B)(6) DISTAL HUB HAD SOME MECHANICAL DAMAGE AND A CUT PRESSURE TUBING CONNECTOR WAS ATTACHED TO IT. IT APPEARS THAT AN ATTEMPT TO DETACH THE HUB FROM THE PRESSURING TUBING WAS MADE WITH HEMOSTATS, WHICH MADE SOME INDENTATIONS IN THE MATERIALS. THERE WAS NO VISIBLE DAMAGE OBSERVED FROM RETURNED THE MONOJECT 1.5CC LIMITED VOLUME SYRINGE. THE INTRODUCER WAS NOT RETURNED. VISUAL EXAMINATION WAS PERFORMED UNDER 10 X MAGNIFICATIONS. NO DEFECT OR DAMAGES, OTHER THAN THE MATERIAL DAMAGE PREVIOUSLY DESCRIBED, WERE FOUND ON THE RETURNED CATHETER. NO ABNORMALITIES WERE NOTED DURING FUNCTIONAL TESTING. AFTER REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION THAT THE EVENT REPORTED WAS RELATED TO THE DESIGN OR MANUFACTURE OF THE CATHETER. PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT THE PATIENT DIED AFTER A PULMONARY ARTERY PERFORATION DURING RIGHT HEART CATHETERIZATION. THE PATIENT WAS BEING WORKED UP AS A VENTRICULAR ASSIST DEVICE AND TRANSPLANT CANDIDATE. THE CATHETER WAS ADVANCED BY THE MD AND AN X-RAY WAS OBTAINED TO CONFIRM PLACEMENT. A HEMODYNAMIC PROFILE WAS ORDERED AND THE CATHETER WEDGED WITHOUT RESISTANCE. FOLLOWING THE WEDGE, THE PATIENT BEGAN COUGHING, WAS INITIALLY STABLE BUT RAPIDLY PROGRESSED TO ARREST AND PATIENT EXPIRED. DURING FOLLOW-UP WITH THE CLINICAL NURSE SPECIALIST FROM CVIS, IT WAS NOTED THAT SHE WAS NOT SURE IF THE BALLOON WAS INFLATED OR IF IT HAD RUPTURED AND THE NURSE FELT THAT EVENT HAD NOTHING TO DO WITH THE SWAN-GANZ CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ HI-SHORE TRUE SIZE THERMODILUTION CATHETER WITH AMC THROMBOSHIELD THERMODILUTION CATHETER DYG EDWARDS LIFESCIENCES, PR 141HF7

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death