BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 2147993 · Received July 2, 2011

    Report

    Report Number
    3008500478-2011-00124
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROCESS.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION: 07/23/2011. DEVICE MANUFACTURE DATE: 02/23/2011. DEVICE EVALUATION: COLORED WATER WAS INTRODUCED INTO THE BALLOON LUMEN AND VISUALLY THERE IS A FLUID PATH WERE THE DISTAL BALLOON BOND HAS DELAMINATED. WATER WAS INTRODUCED INTO THE PRESSURE AND INFUSION LUMENS AND THE WATER FLOWS FROM WHERE IT SHOULD. THE DEVICE WAS VISUALLY INSPECTED AND THERE ARE NO OTHER DEFECTS DETECTED. THESE DEVICES ARE VISUALLY AND FUNCTIONALLY TESTED 100% PRIOR TO PACKAGING. A PRODUCT RISK ASSESSMENT WAS INITIATED FOR CORONARY SINUS CATHETER DISTAL BALLOON BOND FAILURE AND IS APPLICABLE TO THIS EVENT. A CAPA WAS OPENED FOR INVESTIGATION INTO EP BALLOON BOND DELAMINATION AND IS APPLICABLE TO THIS EVENT. TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDOPLEGE CATHETER BALLOON HAD A HOLE THAT WAS NOTICED DURING INFLATION, PRIOR TO INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 821595

    Patients

    Seq Age Sex Outcome Treatment
    1