BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION PACEPORT CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2230143 · Received September 1, 2011

    Report

    Report Number
    2015691-2011-16126
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    LDF
    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 INFLATED AND DEFLATED, AND THERE WAS NO OCCLUSION FOUND. THE BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. THE BALLOON DEFLATED IN 2 SECONDS WITHOUT A SYRINGE ATTACHED. THE BALLOON FAILED TO DEFLATE WITH SYRINGE ATTACHED. PER INSTRUCTIONS FOR USE (IFU), "PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE FROM THE GATE VALVE". ALL THROUGH LUMENS WERE TESTED FOR PATENCY AND LEAKAGE AND ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED ON THE CATHETER BODY OR THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. VISUAL EXAMINATION WAS PERFORMED UNDER 10 X MAGNIFICATION. THE COMPLAINT COULD NOT BE CONFIRMED DURING ANALYSIS; THE CATHETER PERFORMED APPROPRIATELY DURING ANALYSIS. POTENTIAL CONTRIBUTING FACTORS CANNOT BE DETERMINED AT THIS TIME. THERE WAS NO EVIDENCE OF A MANUFACTURING DEFECT; NO ACTIONS WILL BE TAKEN AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT THE DEVICE MET 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 LDF EDWARDS LIFESCIENCES, PR 931HF75 58960112

    Patients

    Seq Age Sex Outcome Treatment
    1