BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 2220854 · Received August 23, 2011

    Report

    Report Number
    3008500478-2011-00134
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 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

    DEVICE EVALUATION: THE DEVICE BALLOON WAS VISUALLY INSPECTED UNDER 10X MAGNIFICATION AND VISUALLY THE BALLOON HAS BURST. THE EDGES OF THE BURST ARE SMOOTH HOWEVER THERE IS SIGNIFICANT THINNING IN THE AREA THAT BURST. VISUALLY THERE IS A SUBTLE KINK IN THE BELLOWS. THERE ARE NO OTHER VISUAL DEFECTS DETECTED. WATER WAS INTRODUCED THROUGH ALL OF THE DEVICE LUMENS AND THE WATER FLOWS FROM WHERE IT SHOULD WITH ACCEPTION TO THE BALLOON LUMEN WHICH IS PLUGGED WITH DRIED BLOOD. THERE ARE NO OTHER DEFECTS DETECTED WITH THIS DEVICE. THESE DEVICES ARE VISUALLY AND FUNCTIONALLY TESTED 100% PRIOR TO PACKAGING. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ENDOPLEGE CATHETER BALLOON RUPTURE DURING USE. THE EVENT DATE WAS (B)(6) 2011 DURING A MINI MVR WITH (B)(6). THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 856535

    Patients

    Seq Age Sex Outcome Treatment
    1