BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1820269 · Received August 30, 2010

    Report

    Report Number
    2015691-2010-13966
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K040287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORT WAS CONFIRMED. THE CATHETER WAS FOUND TO HAVE WHAT APPEARS TO BE A CUT IN THE OUTER BODY TUBE, LOCATED 45CM PROXIMAL OF THE CATHETER TIP. THE BALLOON DOES NOT MAINTAIN INFLATION DUE TO THE CUT IN THE CATHETER BODY ENTERING THE INFLATION LUMEN. THE CONTAMINATION SHIELDED AND INTRODUCER WERE NOT RETURNED, 1.5CC SYRINGE WAS RETURNED. THE REMAINING THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OBSERVED. THESE CATHETERS ARE LEAK TESTED AND THE BALLOONS ARE INFLATED DURING THE MANUFACTURING PROCESS. CUTS IN THE CATHETER, ENTERING THE INFLATION LUMEN, WOULD CAUSE THE PRODUCT TO BE REJECTED DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DIRECTIONS FOR USE INSTRUCT THE CUSTOMER TO FLUSH THE DEVICE AND TEST THE BALLOON PRIOR TO USE. CUTS IN THE CATHETER, ENTERING THE INFLATION LUMEN, WOULD PREVENT THE BALLOON FROM INFLATING DURING PREP. CATHETER PREPARATION FLUSH THE CATHETER LUMENS WITH A STERILE SALINE OR DEXTROSE SOLUTION TO INSURE PATENCY AND TO REMOVE AIR. CHECK BALLOON INTEGRITY BY INFLATING IT TO THE RECOMMENDED VOLUME. CHECK FOR MAJOR ASYMMETRY AND FOR LEAKS BY SUBMERGING IN STERILE SALINE OR WATER. DEFLATE BALLOON BEFORE INSERTION. ALTHOUGH THE ROOT CAUSE FOR THE CUTS ON THE CATHETER CANNOT BE CONFIRMED, THERE IS NO EVIDENCE OF A MANUFACTURING RELATED DEFECT. THE CUTS APPEAR TO HAVE BEEN CAUSED BY AN EXTERNAL OBJECT. THE LOT NUMBER WAS NOT PROVIDED AND THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE BALLOON DID NOT INFLATE DURING SET UP, AND IT WAS UNABLE TO USE THE CATHETER." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD CONTINUOUS CARDIAC OUTPUT CATHETER DQE EDWARDS LIFESCIENCES, PR 774HF75J

    Patients

    Seq Age Sex Outcome Treatment
    1