BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 1823112 · Received September 1, 2010

    Report

    Report Number
    1713910-2010-00265
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGE IN OPERATIVE STRATEGYDEVICE WAS DISCARDED BY CUSTOMERADDITIONAL INFORMATION WAS REQUESTED, BUT HAS NOT YET BEEN RECEIVED. AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN, AND THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION AN EVALUATION CANNOT BE PERFORMED. IF ADDITIONAL INFORMATION REGARDING THE EVENT IS RECEIVED, THE FILE WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCKING MECHANISM ON THE STERILE SHEATH DID NOT WORK AND THE ENDOPLEGE CATHETER SLIPPED OUT OF THE CORONARY SINUS WHEN THE CUSTOMER POSITIONED IT, CONSEQUENTLY THE SURGEON DECIDED TO DO THE CASE THROUGH A STERNOTOMY RATHER THAN RT. THORACOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other