BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS LIFESCIENCE ENDOPLEGE SINUS CATHETER KIT

    MDR report key: 1696450 · Received May 18, 2010

    Report

    Report Number
    MW5016014
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 18, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, LLC
    Product Code
    DXF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLOSE CALL -- USER EXPECTED DEVICE TO OPERATE DIFFERENTLY -HAVE A LOCK-IN MECHANISM- THAN IT DID. PHYSICIAN PLACED A CORONARY SINUS CATHETER IN CONJUNCTION WITH A MINIMALLY INVASIVE CARDIAC SURGERY, AND WAS SURPRISED TO DISCOVER THAT IT WAS NOT POSSIBLE TO LOCK THE CATHETER IN PLACE. THE SAME CATHETER PREVIOUSLY HAD A LOCK-IN MECHANISM. THE PHYSICIAN SECURED THE CATHETER BY TAPE, THE OPERATION WAS SUCCESSFUL AND UNEVENTFUL, AND NO PATIENT HARM OCCURRED. THE CORONARY SINUS CATHETER IS USED TO GIVE CARDIOPLEGIA TO THE PATIENT AND PROTECT THE MYOCARDIUM DURING MINIMAL INVASIVE CARDIAC SURGERY. IF THE CATHETER BECOMES DISLODGED DURING THE PROCEDURE, THE SURGEON HAS TO OPEN THE STERNUM ON TOP OF THE THORACOTOMY THAT HAS ALREADY BEEN DONE. IN A SUBSEQUENT CALL TO THE MANUFACTURER'S REPRESENTATIVE WE LEARNED THE PREVIOUS DESIGN OF THIS SAME CATHETER HAD A LOCK-IN MECHANISM; THE NEW DESIGN DOES NOT HAVE A LOCK-IN MECHANISM AND NOW USERS MUST SECURE THE CATHETER VIA TAPE, CONSIDERED TO BE A LESS SECURE METHOD. TWO ISSUES: AT LEAST ONE PHYSICIAN PREFERS THE LOCK-IN MECHANISM TO SECURE THE CATHETER AND BELIEVES THIS IS FAR SAFER THAN TAPE. CONSIDERATION OF THIS FEATURE SHOULD BE GIVEN IN THE RE-DESIGN OF THIS PRODUCT. INEFFECTIVE COMMUNICATION TO END-USERS REGARDING CATHETER DESIGN CHANGE. NO CLINICIAN SHOULD BE SURPRISED ABOUT THE LACK OF A LOCK-IN MECHANISM AFTER THE PLACEMENT OF THE CATHETER INSIDE THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESCIENCE ENDOPLEGE SINUS CATHETER KIT ENDOPLEGE SINUS CATHETER KIT - 9FR 3MM X 18.9 INCHES DXF EDWARDS LIFESCIENCES, LLC EP 718995

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR