BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION PACEPORT CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2230135 · Received August 31, 2011

    Report

    Report Number
    2015691-2011-16125
    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
    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 NO OCCLUSION WAS FOUND. THE BALLOON INFLATED CLEARLY; HOWEVER, THE BALLOON INFLATED ECCENTRICALLY BY 0.10", WHICH IS NOT WITHIN SPECIFICATION. BUBBLES WERE OBSERVED ON THE LATEX. THE BALLOON WAS INFLATED TO FULL VOLUME AND BALLOON DEFLATED WITHIN 3 SECONDS WITHOUT A SYRINGE ATTACHED. BALLOON FAILED TO DEFLATE WITH SYRINGE ATTACHED. PER INSTRUCTION FOR USE (IFU), "PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE FROM THE GATE VALVE". CONTAMINATION SHIELD AND INTRODUCER WERE NOT RETURNED. 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 AND THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. VISUAL EXAMINATION WAS PERFORMED UNDER 10 X MAGNIFICATION. THE DEFLATION DIFFICULTY COULD NOT BE CONFIRMED; HOWEVER, BALLOON ECCENTRICITY WAS NOTED. THERE WAS NO EVIDENCE OF A MANUFACTURING DEFECT; 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

    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 58988779

    Patients

    Seq Age Sex Outcome Treatment
    1