BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 2063587 · Received April 19, 2011

    Report

    Report Number
    3008500478-2011-00085
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGE IN OPERATIVE STRATEGY. DEVICE WAS DISCARDED BY CUSTOMER. CURRENT INVESTIGATION DOES NOT INDICATE A MANUFACTURING DEFECT OR A TREND THEREFORE NO CAPA WILL BE INITIATED AT THIS TIME. 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 WHEN THE ANESTHESIOLOGIST PUT THE GUIDEWIRE IN FOR THE ENDOPLEGE CORONARY SINUS CATHETER, THE SALES REP TOLD HIM TO CHECK ATRIUM TO MAKE SURE IT WAS IN PLACE. AS SOON AS THE ENDOPLEGE WAS INTRODUCED THE PRESSURE WAS HIGH, APPROX 35. SO THE SALES REP KNEW IT WASN'T IN CENTRAL VENOUS SYSTEM. ACCORDING TO THE REP, THE ANESTHESIOLOGIST PERFORATED THE SVC WITH THE DILATOR, WHICH RESULTED IN THE ENDOPLEGE BEING KINKED. THEY USED FLOURO AND DETERMINED CATHETER WAS IN WRONG POSITION. THE CATHETER WAS PULLED OUT AND IT HAD A KINK IN IT. THE SALES REP RECOMMENDED USING A NEW ENDOPLEGE. SO THEY USED A SECOND ENDOPLEGE, THE ANESTHESIOLOGIST TOOK OUT THE INTRODUCER AND REPOSITIONED IT. HE RESTUCK IJ. THE SECOND ENDOPLEGE WAS PLACED WITHOUT A PROBLEM. HOWEVER, WHEN THE SURGEON STARTED INCISION FOR THE RT. THORACOTOMY HE NOTICED BLOOD IN THE CHEST. BLOOD WAS OUTSIDE OF PERICARDIUM. SURGEON COULD NOT FIGURE OUT WHERE THE BLOOD WAS COMING FROM. HE DECIDED TO CONVERT TO STERNOTOMY TO BE SAFE TO TRY TO FIGURE OUT WHERE BLEEDING WAS COMING FROM BEFORE HE GAVE HEPARIN. THE REST OF THE CASE WENT FINE; THE ENDOPLEGE WORKED FINE, CLOSED PATIENT AND THERE WAS NO BLEEDING. THE DEVICE WAS NOT SAVED BECAUSE BOTH THE SURGEON, ANESTHESIOLOGIST AND SALES REP DID NOT FEEL IT WAS A DEVICE PROBLEM.

    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