BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE T-TIP TD CATHETER WITH AMC THRO

    MDR report key: 3043500 · Received April 9, 2013

    Report

    Report Number
    2015691-2013-19774
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    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 ATTACHED B. BRAUN 3/4CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. NO INTRODUCER WAS RETURNED. THE THERMISTOR WAS SUBMERGED IN A 37.0C WATER BATH AND READ 37.0C ON VIGILANCE II MONITOR. THE THERMISTOR CIRCUIT WAS CONTINUOUS AND THERE WERE NO OPEN OR INTERMITTENT CONDITIONS. THE THERMISTOR CONNECTOR WAS OPENED AND NO VISIBLE INCONSISTENCIES WERE FOUND. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THE BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. NO VISIBLE DAMAGE WAS OBSERVED ON THE CATHETER BODY OR RETURNED SYRINGE. BALLOON INFLATION TEST WAS PERFORMED USING RETURNED SYRINGE WITH 3/4CC AIR. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION AND UNAIDED EYE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE COMPLAINT OF INACCURATE VALUES COULD NOT BE CONFIRMED DURING THE EVALUATION. NO INDICATION OF A MANUFACTURING DEFECT WAS NOTED DURING THE ANALYSIS. IT COULD NOT BE DETERMINED IF ANY CLINICAL OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "INACCURATE CO VALUE WAS OBSERVED DURING USE. THE CATHETER WAS REPLACED AND THE PROBLEM WAS SOLVED." THE VALUE SHOWN ON THE MONITOR IS UNKNOWN. IT IS ALSO UNKNOWN IF THE ERROR MESSAGES WERE OBSERVED OR IF ANY ABNORMALITIES IN THE CATHETER WERE NOTED. THE SAMPLE OF TRACING WAS NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146220 SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE T-TIP TD CATHETER WITH AMC THRO SWAN-GANZ CATHETER DQO EDWARDS LIFESCIENCES, PR T173HF6 59386937

    Patients

    Seq Age Sex Outcome Treatment
    1