BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 2212442 · Received August 16, 2011

    Report

    Report Number
    3008500478-2011-00132
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: AN ATTEMPT WAS MADE TO INFLATE THE BALLOON WITH 2CC OF AIR. THE INFLATION WAS UNSUCCESSFUL. AN .014 GUIDEWIRE WAS USED TO TEST IF THE INFLATION LUMEN WAS BLOCKED. THE GUIDEWIRE ADVANCED ALL THE WAY TO THE DISTAL TIP AND VISUALLY UNDER 10X WHEN THE GUIDEWIRE IS ADVANCED INTO THE INFLATION LUMEN THE GUIDEWIRE GOES INTO THE SOFT TIP AND NOT THROUGH THE INFLATION NOTCH. THE GUIDEWIRE WAS REMOVED FROM THE INFLATION LUMEN AND IT WAS INSERTED INTO THE PRESSURE LUMEN. WHEN THE GUIDEWIRE CAME OUT OF THE PRESSURE NOTCH IT WAS ALSO OBSERVED THAT THE GUIDEWIRE COULD BE SEEN THROUGH THE INFLATION NOTCH INSIDE OF THE BALLOON. THE BALLOON WOULD NOT INFLATE BECAUSE THE INFLATION NOTCH IS NOT IN THE CORRECT PLACE TO ACHIEVE INFLATION OF THE BALLOON. WATER WAS INTRODUCED THROUGH THE PRESSURE AND INFUSION LUMENS AND THE WATER FLOWS FROM WHERE IT SHOULD. THERE ARE NO OTHER DEFECTS DETECTED WITH THIS DEVICE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THIS IS CONSIDERED AN ISOLATED INCIDENT THEREFORE NO CAPA WILL BE OPENED. THIS IS THE FIRST TIME THIS DEFECT HAS BEEN SEEN. AS A PRECAUTION, TRAINING WAS PERFORMED TO MAKE OPERATORS AWARE OF THE PROBLEM. TRENDS WILL CONTINUE TO BE MONITORED FOR FUTURE OCCURRENCE AND ANY NEGATIVE TRENDS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ENDOPLEGE CATHETER BALLOON PORT WAS "TOTALLY BLOCKED." THE BALLOON WAS NOT ABLE TO BE INFLATED; IT WAS SWITCHED OUT FOR ANOTHER AND THERE WERE NO PATIENT COMPLICATIONS AS IT WAS NEVER USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 856528

    Patients

    Seq Age Sex Outcome Treatment
    1