BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVENT PULMONARY VENT

    MDR report key: 3875199 · Received June 16, 2014

    Report

    Report Number
    3008500478-2014-00086
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS UNDER EVALUATION INTO ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    AS REPORTED A ENDOVENT HAD A LEAKAGE DURING PROCEDURE. THE SURGEON INSERTED THE INTRODUCER OF THE ENDOVENT IN THE INTERNAL JUGULAR VEIN OF THE PATIENT. HE NOTED ABNORMAL LEAKAGE OF BLOOD IN THE INTRODUCER (JUNCTION OF GREEN AND WHITE, AT THE MAIN PORT FOR INTRODUCTION OF THE ENDOVENT. IT WAS LEAKING SO MUCH THAT THEY HAVE DECIDED TO REMOVE THE INTRODUCER(2014-05503-1). THEY OPENED A NEW ENDOVENT PACKAGE, DURING USE OF THIS NEW EV A NEW LEAK WAS NOTED, LESS THAN THE PREVIOUS ONE (IN THE SAME POSITION). THEY HAVE DECIDED TO LEAVE THE INTRODUCER IN PLACE TO USE THE ENDOVENT AND USED A BAND-AID TO STOP THE LEAKAGE (2014-05503-2). ONLY THE FIRST DEVICE IS AVAILABLE TO RETURN. AS PER FOLLOW UP IT WAS CONFIRMED, THEY USED THE INTRODUCER PROVIDED IN THE ENDOVENT KIT. EVALUATION: THE DEVICE WAS DISCARDED BY THE HOSPITAL AND UNAVAILABLE FOR EVALUATION. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE OF THE LEAK WAS UNABLE TO BE DETERMINED. TRENDS FOR THIS ISSUE ARE IN CONTROL AND WILL CONTINUE TO BE MONITORED. MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO RELATED NON CONFORMANCES IDENTIFIED. THERE WILL BE NO PRA OR CAPA INITIATED AT THIS TIME. THE INSTRUCTIONS FOR USE, TRAINING, AND RISK CONTROL MEASURES ARE APPROPRIATE AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE EDWARDS QUALITY SYSTEM.

    Description of Event or Problem · 1

    AS REPORTED A ENDOVENT, EV, HAD A LEAKAGE DURING PROCEDURE. THE SURGEON INSERTED THE INTRODUCER OF THE ENDOVENT IN THE INTERNAL JUGULAR VEIN OF THE PATIENT. THEY OPENED A ENDOVENT PACKAGE, DURING USE OF THIS EV A LEAK WAS NOTED. THEY HAVE DECIDED TO LEAVE THE INTRODUCER IN PLACE TO USE THE ENDOVENT AND USED A BAND-AID TO STOP THE LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352046 ENDOVENT PULMONARY VENT CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES EV 59697464

    Patients

    Seq Age Sex Outcome Treatment
    1