BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 3913846 · Received July 3, 2014

    Report

    Report Number
    3008500478-2014-00098
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K120780
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETAINED BY THE HOSPITAL FOR EVALUATION. AT THIS TIME, THERE IS NO ALLEGATION OF PRODUCT MALFUNCTION BUT ONLY AN ADVERSE EVENT ASSOCIATED WITH THE USE OF AN EDWARDS DEVICE. THE DEVICE WAS DISCARDED AT THE HOSPITAL. INJURIES TO THE RIGHT VENTRICLE ARE LISTED AS A POTENTIAL COMPLICATION IN THE PRODUCT IFU. THE IFU FURTHER NOTES: WARNING: IF RESISTANCE IS MET, STOP AND RE-EVALUATE PROPLEGE DEVICE POSITION. THE PROPLEGE DEVICE SHOULD NOT BE ADVANCED IF RESISTANCE IS FELT, AS DOING SO WOULD CAUSE THE PROPLEGE DEVICE TO BEND OR BUCKLE. AGGRESSIVE ADVANCEMENT IN AN ATTEMPT TO ENGAGE THE OSTIUM MAY RESULT IN PERFORATION OR OTHER INJURY. WARNING: CONTINUOUSLY MONITOR THE PRESSURE AT THE TIP OF THE CATHETER. A PRESSURE CHANGE THAT INDICATES THE CATHETER HAS ENTERED THE RIGHT VENTRICLE SHOULD BE NOTED. DO NOT ADVANCE THE CATHETER FURTHER IF THE TIP IS IN THE RIGHT VENTRICLE AS PERFORATION OR OTHER INJURY CAN OCCUR. WARNING: AGGRESSIVE ADVANCEMENT OF THE GUIDEWIRE IN AN ATTEMPT TO ENGAGE THE OSTIUM MAY RESULT IN PERFORATION OR OTHER INJURY. NO DEVICE MALFUNCTION IS INDICTED IN THE REPORT AND THE EVENTS REPORTED ARE INCLUDED IN THE LABELING. NO ACTIONS ARE NEEDED AT THIS TIME THIS TYPE OF EVENT IS A KNOWN POTENTIAL COMPLICATION AND/OR ADVERSE EVENT, IS INCLUDED IN THE LABELING/TRAINING MATERIALS, AND IN THE INFORMATION WE PROVIDE TO HELP AVOID THE ISSUE. ALL LABELING AND TRAINING APPROPRIATELY ADDRESS THE RISK. MANUFACTURING RECORDS COULD NOT BE REVIEWED AS A LOT NUMBER IS UNKNOWN. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE USE OF EDWARDS QUALITY SYSTEMS.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS RECEIVED THAT THE ANESTHESIOLOGIST INDICATED THAT FLUOROSCOPY WAS USED DURING THE CASE AND THE CATHETER NEVER CROSSED THE TRICUSPID VALVE AND THEREFORE IT WAS UNLIKELY THE DEVICE CAUSED THE PERFORATION.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE CASE WAS A ROBOTIC MITRAL VALVE REPLACEMENT WITH PROPLEGE CORONARY SINUS CATHETER. THE CASE PROCEEDED AS PLANNED BUT WHEN THE SURGEON OPENED THE PARICARDIUM HE NOTICED SOME BLOOD. THE TEAM PROCEEDED WITH THE CASE, THE VALVE WAS REPAIRED AND THE PATIENT WAS WEANED FROM BYPASS. ALL CANNULAS WERE REMOVED, PROTAMINE WAS GIVEN AND ALL INCISIONS WERE CLOSED. UPON REMOVAL OF THE DRAPES THE PATIENT CODED AND THE STERNUM WAS OPENED AT WHICH TIME A HOLE WAS FOUND IN THE RIGHT VENTRICLE. IT APPEARED TO THE SURGEON TO BE A RESULT OF A PERFORATION BY THE PROPLEGE CORONARY SINUS CATHETER. THE HOLE WAS REPAIRED, THE PATIENT WAS CLOSED AND MOVED TO THE ICU AND IS DOING FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389131 PROPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other