BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ GLIDE AORTIC CANNULA

    MDR report key: 3841600 · Received May 30, 2014

    Report

    Report Number
    3008500478-2014-00076
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K123370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETAINED BY THE HOSPITAL FOR EVALUATION. AT THIS TIME, THERE IS NO ALLEGATION OF PRODUCT MALFUNCTION BUT ONLY AN ADVERSE EVENT ASSOCIATED WITH THE USE OF AN EDWARDS DEVICE. THE EVENT WAS PRESENTED BY THE EDWARDS SALES REP AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO DEVICE MALFUNCTION IS INDICTED IN THE REPORT. AT THIS TIME, NO ACTIONS ARE NEEDED. ALL LABELING AND TRAINING APPROPRIATELY ADDRESS THE RISK. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE EZ GLIDE AORTIC CANNULA THAT THERE HAVE BEEN THREE PERIAORTIC DISSECTIONS. THE CUSTOMER DID NOT SPECIFY WHICH EZ GLIDE MODEL WAS IN USE AT THE TIME OF THESE EVENTS. EVENT DATES AND LOT NUMBERS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318444 EZ GLIDE AORTIC CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES EZS21QTA

    Patients

    Seq Age Sex Outcome Treatment
    1