BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ HI-SHORE TORQUE SUPPORT TRUE SIZE THERMODILUTION CATHETER WITH AMC THR

    MDR report key: 2821029 · Received November 6, 2012

    Report

    Report Number
    2015691-2012-18610
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQO
    PMA / PMN Number
    K915726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WITH MONOJECT 1.5CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. NO INTRODUCER WAS RETURNED WITH THE CATHETER. AS RECEIVED, SOME WATER DROPS WERE FOUND INSIDE THE SYRINGE BARREL. BALLOON DEFLATION WAS ACHIEVED WITHIN 2 SECONDS WITHOUT THE SYRINGE ATTACHED, AND IT WAS CONFIRMED TO BE WITHIN SPECIFICATION. THE BALLOON FAILED TO DEFLATE FULLY WITH RETURNED SYRINGE ATTACHED. PER THE IFU, "PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE FROM THE GATE VALVE." THE WATER IN THE SYRINGE OR INFLATION LUMEN COULD HAVE CAUSED OCCLUSION TEMPORARILY AND PREVENTED NORMAL BALLOON DEFLATION. THE BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. NO RESISTANCE WAS FELT DURING THE INJECTION OF AIR. NO VISIBLE DAMAGE AND/OR DETERIORATION OF THE BALLOON LATEX OR BALLOON BONDINGS WAS FOUND. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE TO THE CATHETER BODY OR RETURNED SYRINGE WAS OBSERVED. THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. THE BALLOON INFLATION TEST WAS PERFORMED USING THE RETURNED SYRINGE WITH 1.5CC AIR. BALLOON DEFLATION TESTING WAS DONE ACCORDING TO THE INSTRUCTIONS FOR USE USING THE RETURNED SYRINGE. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION AND WITH THE UNAIDED EYES. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. THE COMPLAINT OF DEFLATION DIFFICULTY COULD NOT BE CONFIRMED DURING THE ANALYSIS, AS THE DEVICE RESPONDED APPROPRIATELY DURING FUNCTIONAL TESTING. NO INDICATION OF A MANUFACTURING DEFECT NOTED DURING THE ANALYSIS. IT IS NOT CLEAR IF THE END-USER ATTEMPTED TO FLUSH THE INFLATION LUMEN DURING THE SET-UP PROCESS. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON DID NOT DEFLATE AT THE INFLATION TEST BEFORE USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ HI-SHORE TORQUE SUPPORT TRUE SIZE THERMODILUTION CATHETER WITH AMC THR SWAN-GANZ CATHETER DQO EDWARDS LIFESCIENCES, PR 171HF7

    Patients

    Seq Age Sex Outcome Treatment
    1