BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLAMP AORTIC CATHETER

    MDR report key: 2063561 · Received April 19, 2011

    Report

    Report Number
    3008500478-2011-00086
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 1, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT 774598 AND THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6) 2011: EVALUATION RESULTS: THE DEVICE BALLOON WAS VISUALLY INSPECTED UNDER 10X MAGNIFICATION AND IT IS CONFIRMED THAT THE BALLOON HAS BURST. THE BURST IS AROUND THE CIRCUMFERENCE OF THE BALLOON AND VISUALLY THE EDGES OF THE BURST ARE SMOOTH AND EVEN IN WALL THICKNESS. THE ENTIRE DEVICE WAS VISUALLY INSPECTED AND THERE ARE NO OTHER DEFECTS DETECTED. 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. FURTHER INVESTIGATION IS CURRENTLY BEING PERFORMED BY EDWARDS ENGINEERING IN (B)(6).

    Additional Manufacturer Narrative · 1

    EDWARDS FURTHER INVESTIGATION: (B)(6) 2011- THE BALLOON WAS VISUALLY INSPECTED UNDER 10 X MAGNIFICATION AND IT IS CONFIRMED THAT THE BALLOON HAS BURST. THE BURST IS AROUND THE CIRCUMFERENCE OF THE BALLOON AND VISUALLY THE EDGES OF THE BURST ARE SMOOTH AND EVEN IN WALL THICKNESS. THE BURST IS AROUND THE CIRCUMFERENCE OF THE BALLOON AND VISUALLY THE EDGES OF THE BURST ARE SMOOTH AND EVEN IN WALL THICKNESS. THE ENTIRE DEVICE WAS VISUALLY INSPECTED AND THERE ARE NO OTHER DEFECTS DETECTED. THE ROOT CAUSE OF WHAT CAUSED THE BALLOON TO TEAR IN THIS MANNER CANNOT BE DETERMINED. THE EDGES OF THE BURST ARE SMOOTH AND EVEN IN THICKNESS. ALL PREVIOUS BALLOON BURST COMPLAINTS EVALUATED SHOWED THE EDGE OF THE BALLOON TO THIN OUT, THE EDGE TO BE JAGGED AND THE BALLOON TO DEVELOP AN ECCENTRIC SET DUE TO THE BURST. THIS BALLOON DOES NOT EXHIBIT ANY OF THESE CHARACTERISTICS. A MANUFACTURING NONCONFORMANCE CANNOT BE CONFIRMED AND THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. SINCE THE ROOT CAUSE OF THIS DEFECT COULD NOT BE DETERMINED; AND THE REVIEW OF THE COMPLAINTS INDICATE THAT THIS IS AN ISOLATED INCIDENT NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, THE BALLOON BURST IN THE MIDDLE OF THE PROCEDURE WHEN (B)(6) HAD NOT YET COMMENCED THE SUTURES. THE BALLOON WAS MOBILIZED BY THE SURGEON THEN IT WAS INFLATED; NO PRESENCE OF ATHEROSCLEROTIC PLAQUE OR CALCIUM IN THE AORTA. (B)(6) THEN DECIDED TO CONVERT TO STERNOTOMY. WHEN REMOVING THE ENDOCLAMP, HE SAW THAT IT WAS SPLIT INTO 2CMS APPROXIMATELY. PATIENT WAS CONVERTED TO STERNOTOMY HOWEVER NO SPECIAL CONCERNS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCLAMP AORTIC CATHETER AORTIC CATHETER, CLAMP DXC EDWARDS LIFESCIENCES EC1001 774598

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR