BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOL-X GLIDE PROTECTION DEVICE

    MDR report key: 901878 · Received August 21, 2007

    Report

    Report Number
    6000002-2007-05011
    Event Type
    Malfunction
    Date Received
    August 21, 2007
    Date of Event
    April 4, 2007
    Report Date
    April 23, 2007
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PLUG HAD BROKEN INTO SMALL PIECES WITHIN THE CANNULA. DRY BLOOD WAS VISIBLE THROUGHOUT THE PLUG.

    Description of Event or Problem · 1

    C-BN-110-BROKE DURING USE. VENT CAP OF THE EMBOL-X GLIDE ACCESS DEVICE WAS INSERTED IN THE AORTA. CANNULA WAS SECURE IN PLACE WITH SLIDES AND HEAVY TIES. TUBING CLAMP WAS PLACED ON CANNULA. ATTEMPT WAS MADE TO REMOVE THE WHITE CAP OF THE VENT CAP FROM THE CANNULA WHEN THE CAP BROKE OFF, LEAVING THE TIP OF THE WHITE CAP IN THE CANNULA. THE SURGEON REMOVED PARTICLES OF THE CAP WITH A STRAIGHT CLAMP. HE FOLLOWED WITH IRRIGATING THE CANNULA UP TO THE CLAMP WITH PROFUSE AMOUNT SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOL-X GLIDE PROTECTION DEVICE AORTIC FILTER, PERFUSION CANNULA DWF EDWARDS LIFESCIENCES RESEARCH MEDICAL EXGF24LLD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR