BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION PACEPORT CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2230108 · Received August 31, 2011

    Report

    Report Number
    2015691-2011-16124
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K803058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION PRIOR TO THE DECONTAMINATION PROCESS FOUND THAT THE BALLOON WOULD NOT INFLATE, THE LATEX APPEARED INTACT, AND NO OCCLUSION WAS FOUND. THE CATHETER WAS RECEIVED WITH THE CONTAMINATION SHIELD ATTACHED TO THE CATHETER. THE BALLOON AND CATHETER BODY WERE IMMERSED IN WATER TO VISUALLY EXAMINE ANY SOURCE OF LEAKAGE. THE BALLOON WAS FOUND TO BE SEVERELY DETERIORATED (DRY AND CRACKING OVER THE ENTIRE SURFACE OF BALLOON LATEX). LEAKAGE WAS SEEN ALL OVER BALLOON LATEX. ALL THROUGH LUMENS WERE TESTED FOR PATENCY AND LEAKAGE AND NO LEAKAGE OR OCCLUSION WAS FOUND. INTRODUCER AND CONTAMINATION SHIELD WERE NOT RETURNED. NO VISIBLE DAMAGE WAS OBSERVED ON THE CATHETER BODY OR RETURNED THE MONOJECT 1.5CC LIMITED VOLUME SYRINGE. VISUAL EXAMINATION WAS PERFORMED UNDER 10 X MAGNIFICATIONS. THE DEFLATION DIFFICULTY COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE LATEX; THE BALLOON WAS UNABLE TO INFLATE. STORAGE CONDITIONS OF THE PRODUCT WAS NOT REPORTED. THERE WAS NO EVIDENCE OF A MANUFACTURING DEFECT; NO ACTIONS WILL BE TAKEN AT THIS TIME. ALTHOUGH THE CAUSE OF THE LATEX DETERIORATION COULD NOT BE DETERMINED A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE ON ITS OWN. NO OTHER INFORMATION WAS KNOWN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ THERMODILUTION PACEPORT CATHETER WITH AMC THROMBOSHIELD THERMODILUTION PACEPORT CATHETER DYG EDWARDS LIFESCIENCES, PR 931HF75 58942094

    Patients

    Seq Age Sex Outcome Treatment
    1