BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCLAMP AORTIC CATHETER

    MDR report key: 1994212 · Received February 17, 2011

    Report

    Report Number
    3008500478-2011-00049
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVALUATION: (B)(6) 2011 THE DEVICE BALLOON WAS VISUALLY INSPECTED UNDER 10X MAGNIFICATION AND IT IS CONFIRMED THAT THE BALLOON HAS BURST. THE EDGES OF THE BURST ARE SMOOTH, HOWEVER THERE IS SIGNIFICANT THINNING IN THE AREA THAT BURST. WATER WAS INTRODUCED THROUGH ALL OF THE DEVICE LUMENS AND THE WATER FLOWS FROM WHERE IT SHOULD. THERE ARE NO OTHER DEFECTS DETECTED WITH THIS DEVICE. THESE DEVICES ARE VISUALLY AND FUNCTIONALLY TESTED 100% PRIOR TO PACKAGING. THE ROOT CAUSE OF THE BURST BALLOON COULD NOT BE DETERMINED. A DHR REVIEW WAS PERFORMED FOR 774596 AND THIS DEVICE PASSED ALL INSPECTIONS WITH NO NON CONFORMANCES. 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 BALLOON RUPTURED DURING USE, AT THE END OF THE CASE. THERE WERE NO PATIENT COMPLICATIONS OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLAMP AORTIC CATHETER AORTIC CATHETER DXC EDWARDS LIFESCIENCES EC1001 774596

    Patients

    Seq Age Sex Outcome Treatment
    1