BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 1910062 · Received November 30, 2010

    Report

    Report Number
    3008500478-2010-00020
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 21, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: WATER WAS INTRODUCED INTO THE BALLOON AND THERE ARE NO HOLES OR LEAKS DETECTED. THE INFLATION WAS SUSTAINED FOR A HALF HOUR WITH NO LEAKING. WATER WAS INTRODUCED THROUGH THE PRESSURE AND INFUSION LUMENS AND THE WATER FLOWS FROM WHERE IT SHOULD. THE DEVICE WAS VISUALLY INSPECTED AND THERE ARE NO VISUAL DEFECTS DETECTED. THE DISTAL END OF THE DEVICE WAS CLAMPED AND THE DEVICE WAS TESTED FOR INTERLUMEN LEAKAGE. THERE IS NO INTERLUMEN LEAKAGE DETECTED. THE DEVICE WAS PUT INTO AN INTRODUCER FROM STOCK. THE CATHETER DISTAL END OF THE DEVICE WAS PLACED IN A BEAKER OF WATER. THE DEVICE SOAKED FOR APPROX. 4 HOURS. AFTER A PROLONGED SOAK A SYRINGE WAS USED AND TO TRY TO SUCK WATER BACK THROUGH THE DEVICE. THE WATER WOULD GO BACK INTO THE INFUSION LUMEN AND THE PRESSURE LUMEN HOWEVER NO WATER COULD BE DRAWN BACK INTO THE BALLOON. THE FAILURE MODE COULD NOT BE DUPLICATED. IT COULD NOT BE DETERMINED HOW BLOOD BACKED UP INTO THE BALLOON. THE DEVICE FUNCTIONS AS DESIGNED AND THERE WERE NO LEAKS DETECTED. A REVIEW OF THE DEVICE BATCH RECORD WAS PERFORMED FOR RAW MATERIALS, IN-PROCESS, FINISHED GOODS AND STERILIZATION FOR LOT NUMBER 763127 AND THERE WERE NO NON-CONFORMANCES OPENED IN RELATION TO THE NATURE OF THE COMPLAINT. THE DEVICES MET ALL RAW MATERIALS, IN-PROCESS, FINISHED GOODS AND STERILIZATION SPECIFICATIONS UPON RELEASE OF THE PRODUCT. THIS DEVICE WAS MANUFACTURED IN SEPTEMBER 2010. NO CORRECTIVE ACTION WILL PURSUED AT THIS TIME HOWEVER 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 THE CUSTOMER HAD AN ENDOPLEGE CATHETER WITH A RUPTURED BALLOON; THE BALLOON POPPED DURING THE CASE. AFTER THE 3RD RETROGRADE THERE WAS BLOOD BACK IN SYRINGE, CUSTOMER COULD NO LONGER GET PRESSURE. AT THAT POINT 90% OF THE CASE WAS DONE. THEY JUST GAVE ANTEGRADE AT THAT POINT. REPORTEDLY, THE DEVICE WAS FINE WHEN CV TECH TESTED IT BEFORE INSERTION AND WAS FINE DURING PLACEMENT. THEY KNEW IT WAS FINE AFTER PLACEMENT DUE TO CUSTOMER VISUALIZING IT ON FLURO. THE BALLOON WAS NOT OVER INFLATED. THEY NOTICED BLOOD HAD CAME BACK INTO THE SYRINGE. THEY SAVED THE CATHETER. CUSTOMER FURTHER REPORTS THAT THEY USED THESE CATHETERS BEFORE AND HAVE NEVER HAD THIS PROBLEM. NO PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 763127

    Patients

    Seq Age Sex Outcome Treatment
    1