BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 4900305 · Received July 8, 2015

    Report

    Report Number
    2015691-2015-01629
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 16, 2015
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    KRB
    PMA / PMN Number
    K811411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE 131HF7 CATHETER WITH ATTACHED MONOJECT 1.5CC LIMITED VOLUME SYRINGE FOR EXAMINATION. THE REPORTED EVENT OF BALLOON DEFLATION ISSUE WAS NOT CONFIRMED. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. THE BALLOON DEFLATED IN 2 SECONDS WITHOUT A SYRINGE ATTACHED. THE BALLOON FAILED TO DEFLATE FULLY WITH THE RETURNED SYRINGE ATTACHED. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY OR THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. AS STATED IN THE IFU ¿PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE FROM THE GATE VALVE¿. THE REPORTED EVENT WAS NOT CONFIRMED. ALTHOUGH THE CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED, THERE WAS NO INDICATION OF A MANUFACTURING DEFECT NOTED DURING THE ANALYSIS. NO ACTIONS WILL BE TAKEN AT THIS TIME. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE WITH OR WITHOUT THE SYRINGE ATTACHED. THE ISSUE WAS DETECTED BEFORE USE IN THE PATIENT. ANOTHER CATHETER WAS SUCCESSFULLY USED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443732 SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD PROBE, THERMODILUTION KRB EDWARDS LIFESCIENCES PR 131HF7 59991987

    Patients

    Seq Age Sex Outcome Treatment
    1