BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 3870424 · Received June 12, 2014

    Report

    Report Number
    2015691-2014-01372
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    PMA / PMN Number
    K924452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE MODEL # 744HF75 CATHETER WITH AN ATTACHED MONOJECT 3ML SYRINGE WITH 1.5 ML LIMITED VOLUME SYRINGE FOR EXAMINATION. NO INTRODUCER OR PACKAGE WAS RETURNED. THE REPORTED EVENT THAT "THE BALLOON HAS A PERFORATION" WAS NOT CONFIRMED, BUT THE BALLOON FAILING TO MAINTAIN INFLATION WAS CONFIRMED. THE BALLOON FAILED TO MAINTAIN ITS INFLATION DUE TO LEAKAGE FROM A PUNCTURE AND A SCRATCH ON THE CATHETER BODY AT 101 CM FROM TIP. LEAKAGE WAS FOUND FROM THE PUNCTURE WHEN PRESSURIZING THE INFLATION LUMEN WITH A SYRINGE WHILE ENTIRE CATHETER WAS IMMERSED IN WATER. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THERE WAS NO OTHER VISUAL DAMAGE, CONTAMINATION, OR OTHER ABNORMALITIES FOUND ON CATHETER. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. 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 HAD A PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348039 SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER WITH AMC THROMBOSHIELD CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 744HF75 59587490

    Patients

    Seq Age Sex Outcome Treatment
    1