BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 1890047 · Received November 3, 2010

    Report

    Report Number
    3008500478-2010-00001
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: THE DEVICE BALLOON WAS VISUALLY INSPECTED UNDER 10X MAGNIFICATION AND THERE ARE NO HOLES DETECTED IN THE BALLOON. COLORED WATER WAS THEN INTRODUCED INTO THE BALLOON AND THE WATER FLOWS OUT OF THE DISTAL BALLOON BOND. WATER WAS INTRODUCED THROUGH THE SINUS PRESSURE AND INFUSION LUMENS AND THE WATER FLOWS FROM WHERE IT SHOULD. VISUALLY THERE ARE TWO KINKS IN THE DEVICE SHAFT ONE KINK IS 19" FROM THE DISTAL TIP AND THE OTHER 14" FROM THE DISTAL TIP, HOWEVER THESE TWO KINKS DO NOT AFFECT THE WAY THE DEVICE FUNCTIONS. THERE ARE NO OTHER DEFECTS DETECTED WITH THIS DEVICE. 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 26ML. MINIMUM TO CAUSE BALLOON JOINT TO DELAMINATE. A REVIEW OF THE DEVICE BATCH RECORD WAS PERFORMED FOR RAW MATERIALS, IN-PROCESS, FINISHED GOODS AND STERILIZATION FOR LOT NUMBER 763125 AND THIS DEVICE PASSED ALL INSPECTIONS UPON RELEASE OF THE PRODUCT. A CORRECTIVE ACTION ON EP BALLOONS IS OPEN AND IS APPLICABLE TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDOPLEGE CATHETER WAS PLACED THROUGH THE INTRODUCER AND INTO THE CORONARY SINUS-IT WAS NOTED THAT THE VOLUME DID NOT COME BACK INTO THE SYRINGE WHEN THE ANESTHESIOLOGIST WAS TRYING TO OBTAIN VENTRICULARIZATION. HOWEVER, NO BLOOD WAS NOTED TO BE WITHDRAWN INTO THE SYRINGE EITHER. THE ANESTHESIOLOGIST TOOK THE CATH OUT AND NOTED A SMALL HOLE IN THE BALLOON-INDICATING RUPTURE. PROCEDURE WAS A MITRAL VALVE REPAIR; NO ADVERSE PATIENT EVENTS REPORTED, NO PROLONGED OR TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 763125

    Patients

    Seq Age Sex Outcome Treatment
    1