BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 2082332 · Received May 9, 2011

    Report

    Report Number
    3008500478-2011-00093
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONFIRMED DELAMINATION OF THE DISTAL BALLOON BOND. COLORED WATER WAS INTRODUCED INTO THE DEVICE BALLOON AND VISUALLY UNDER 10X MAGNIFICATION THERE IS DELAMINATION OF THE DISTAL BALLOON BOND. VISUALLY THERE IS A FLUID PATH THROUGH THE BOND. WATER WAS INTRODUCED INTO THE PRESSURE AND INFUSION LUMENS AND THE WATER FLOWS FROM WHERE IT SHOULD. VISUALLY THE DEVICE WAS INSPECTED AND THERE IS A KINK IN THE BELLOWS HOWEVER THIS KINK DOES NOT AFFECT THE WAY THE DEVICE FUNCTIONS. THERE ARE NO OTHER DEFECTS DETECTED. A CORRECTIVE ACTION WAS OPENED AND THIS EVENT IS APPLICABLE TO THE CORRECTIVE ACTION.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT 818581 AND THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THIS DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. ONCE IT IS RECEIVED IT WILL BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPPING THE ENDOPLEGE THEY NOTICED A HOLE IN THE BALLOON, IT WAS NOT USED ON THE PATIENT. REPLACED WITH ANOTHER WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 818581

    Patients

    Seq Age Sex Outcome Treatment
    1