BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 1914317 · Received December 3, 2010

    Report

    Report Number
    3008500478-2010-00023
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    January 31, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: 06/19/2011. DATE OF MANUFACTURE:10/19/2010. EVALUATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR ENDOPLEGE LOT 774333 AND THIS DEVICE PASSED ALL INSPECTIONS WITH NO NONCONFORMANCES. ON (B)(4) 2010 - ACCELLENT EVALUATION - COLORED WATER WAS INTRODUCED INTO THE DEVICE BALLOON AND THERE IS DELAMINATION OF THE DISTAL BALLOON BOND. WATER WAS INTRODUCED THROUGH THE PRESSURE AND INFUSION LUMENS AND THE WATER FLOWS FROM WHERE IT SHOULD, HOWEVER, THE INFUSION LUMEN REQUIRES MORE FORCE THAN USUAL TO INTRODUCE WATER. VISUALLY, THERE IS A VERY SHARP KINK AT THE 4 CM MARKER AND THIS KINK DOES AFFECT THE WAY THE WATER FLOWS THROUGH THE INFUSION LUMEN. THERE ARE NO OTHER DEFECTS DETECTED. THESE DEVICES ARE VISUALLY AND FUNCTIONALLY TESTED 100% PRIOR TO PACKAGING. A REVIEW OF POST-STERILE TEST DATA DEMONSTRATES THAT IT REQUIRES AN INFLATION VOLUME OF 8 ML MINIMUM TO CAUSE BALLOON JOINT TO DELAMINATE. CURRENT INVESTIGATION DOES NOT INDICATE A MANUFACTURING DEFECT OR A TREND; THEREFORE, NO CAPA WILL BE INITIATED AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A CORRECTIVE ACTION WAS OPENED ON (B)(4) 2011 TO ADDRESS A NEGATIVE TREND OF DELAMINATION OF DISTAL BALLOON BOND ON THE ENDOPLEGE DEVICE. THIS ISSUE WILL NOW BE TRACKED THROUGH THE SUPPLIER CORRECTIVE ACTION SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDOPLEGE CATHETER DEFLATED WHEN IT WAS FILLED DURING PREP. THERE WAS A SMALL PIN HOLE IN THE BALLOON. DEVICE WAS NEVER USED IN THE PATIENT. CUSTOMER OPENED A NEW EP AND IT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 774333

    Patients

    Seq Age Sex Outcome Treatment
    1