BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2221089 · Received August 23, 2011

    Report

    Report Number
    2015691-2011-16093
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 26, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K040287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RETURNED WITH THE BALLOON LATEX TORN OFF THE CATHETER TIP AND NOT RETURNED. THERE WAS LATEX OBSERVED ON BOTH PROXIMAL AND DISTAL BOND SITES. THE CONTAMINATION SHIELD AND INTRODUCER WERE NOT RETURNED. ALL THROUGH LUMENS WERE TESTED FOR PATENCY AND LEAKAGE AND NO LEAKAGE OR OCCLUSION WAS FOUND. THERE WAS NO VISIBLE DAMAGE OBSERVED ON THE CATHETER BODY OR RETURNED THE MONOJECT 1.5CC LIMITED VOLUME SYRINGE. VISUAL EXAMINATION WAS PERFORMED UNDER 10X AND 40X MAGNIFICATION. THE COMPLAINT OF MISSING BALLOON WAS CONFIRMED; HOWEVER, THERE ARE NO INDICATIONS THAT THIS IS RELATED TO THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THE DAMAGE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THE PRODUCT IFU STATES THE FOLLOWING: GENTLY LIFT THE CATHETER UP AND REMOVE IT FROM THE SILICONE GRIPPER. NOTE: TO AVOID DAMAGING THE BALLOON, DO NOT PULL THE BALLOON THROUGH THE SILICONE GRIPPER. NO ACTIONS WILL BE TAKEN AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTEDLY, THE BALLOON WAS MISSING OUT OF BOX. IT WAS NOTICED BEFORE USE DURING TESTING. THERE WAS NO IMPACT TO THE PATIENT. FOLLOW-UP INVESTIGATION CONFIRMED THAT THERE WAS NO BALLOON AT ALL, NEITHER ON THE CATHETER, NOR DETACHED IN THE PACKAGING. THE DOCTOR CONFIRMED THAT THE CATHETER MAY HAVE BEEN IN CONTACT WITH THE BLOOD FROM THE SYRINGE AND/OR THE INTRODUCER SHEATH BUT IT WAS NOT INTRODUCED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER CONTINOUS CARDIAC OUPTUT THERMODILUTION CATHETER DQE EDWARDS LIFESCIENCES, PR 774F75 58924759

    Patients

    Seq Age Sex Outcome Treatment
    1