BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPLEGE SINUS CATHETER

    MDR report key: 2103421 · Received May 20, 2011

    Report

    Report Number
    MW5020705
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CORONARY SINUS CATHETER WAS PLACED PRIOR TO AORTIC VALVE REPLACEMENT, MINIMALLY INVASIVE THORACOTOMY. AT THE END OF THE PROCEDURE, THE CORONARY SINUS CATHETER AND THE INTRODUCER WERE REMOVED. IT WAS NOTICED THAT PART OF THE CATHETER INTRODUCER WAS SHEARED OFF. CHEST X-RAY WAS TAKEN AND CONFIRMED THE TIP OF THE INTRODUCER OVERLAID THE RIGHT JUGULAR VEIN. THE PT WAS TAKEN TO INTERVENTIONAL RADIOLOGY WHERE THE RETAINED PART OF THE INTRODUCER WAS REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other