BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 4170978 · Received October 14, 2014

    Report

    Report Number
    2015691-2014-02412
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    KRB
    PMA / PMN Number
    K811411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WITH MONOJECT 1.5 CC LIMITED VOLUME SYRINGE ATTACHED AT GATE VALVE WAS RETURNED FOR EVALUATION. THE BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. NO RESISTANCE WAS FELT DURING INJECTING AIR. NO VISIBLE DAMAGE OR DETERIORATION TO THE BALLOON LATEX AND BALLOON BONDING SITES WAS FOUND. THE BALLOON DEFLATED WITHIN SPECIFICATION AT 1 SECOND WITHOUT THE SYRINGE ATTACHED AND WITHIN 2.5 SECONDS WITH THE SYRINGE ATTACHED. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE TO THE CATHETER BODY OR RETURNED SYRINGE WAS OBSERVED. BALLOON INFLATION TEST WAS PERFORMED USING RETURNED SYRINGE WITH 1.5 CC AIR. THE COMPLAINT OF DEFLATION DIFFICULTY COULD NOT BE CONFIRMED DURING THE ANALYSIS, AS THE DEVICE RESPONDED APPROPRIATELY DURING FUNCTIONAL TESTING THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO DEFLATE THE BALLOON BEFORE USE. IT IS UNKNOWN IF THE INFLATION SYRINGE WAS REMOVED FROM THE GATE VALVE OR NOT." NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651774 SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD SWAN-GANZ CATHETER KRB EDWARDS LIFESCIENCES, PR 131HF7J

    Patients

    Seq Age Sex Outcome Treatment
    1