BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLAMP AORTIC CATHETER

    MDR report key: 2601756 · Received March 4, 2009

    Report

    Report Number
    3008500478-2009-00001
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Date of Event
    January 16, 2009
    Report Date
    February 10, 2009
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    WHILE CLOSING THE ATRIUM, AT THE END OF THE PROCEDURE, WITH THE BALLOON STILL INFLATED AND IT BURST FOR UNK REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLAMP AORTIC CATHETER AORTIC CATHETER DQY EDWARDS LIFESCIENCES LLC EC1001 606674

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK