BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3100543 · Received May 8, 2013

    Report

    Report Number
    2015691-2013-20031
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    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

    ONE CATHETER WITH ATTACHED MONOJECT 1.5 CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. AS RECEIVED THE BALLOON LATEX APPEARED TO BE STRETCHED AT THE SECTION THAT REMAINS ATTACHED TO THE DISTAL BOND. LATEX AND ADHESIVE REMAINED ON THE DISTAL BOND. BALLOON WAS BAGGY AROUND THE PROXIMAL BOND. THIS CONDITION HAS SIMILAR APPEARANCE TO LATEX BEING PUSHED PROXIMALLY ON THE CATHETER. IT THE BALLOON WAS OBSERVED TO BE TORN AROUND THE DISTAL PORTION OF THE LATEX AND EXTENDED INTO THE DISTAL BOND. THE EDGES OF THE LATEX APPEARED TO HAVE DIFFERENT SHAPES AND COULD NOT MATCH UP. NO LATEX DETERIORATION WAS OBSERVED. ALL THROUGH LUMENS WERE FOUND TO BE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE TO THE CATHETER BODY OR RETURNED SYRINGE WAS OBSERVED. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 20X MAGNIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE CUSTOMER REPORT WAS CONFIRMED DURING THE EVALUATION; HOWEVER, IT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS AS THERE WAS EVIDENCE THAT THE BALLOON HAD BEEN BONDED TO THE CATHETER. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT DEVICE HANDLING MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE BALLOON DID NOT INFLATE BEFORE USE." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202015 SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD SWAN-GANZ THERMODILUTION CATHETER DQE EDWARDS LIFESCIENCES, PR 774HF75J 59399008

    Patients

    Seq Age Sex Outcome Treatment
    1