BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 1914406 · Received December 3, 2010

    Report

    Report Number
    3008500478-2010-00024
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 17, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION AND INVESTIGATION: (B)(6) 2010-THE DEVICE BALLOON WAS VISUALLY INSPECTED AND THERE IS NO DAMAGE TO THE BALLOON. AN ATTEMPT WAS MADE TO INTRODUCE WATER INTO THE BALLOON LUMEN HOWEVER THE LUMEN IS BLOCKED WITH BLOOD AND FLUIDS AND NO WATER WOULD GO INTO THE BALLOON. VISUALLY UNDER 10X MAGNIFICATION IT IS NOTED THAT 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. THERE ARE NO OTHER DEFECTS DETECTED. A REVIEW OF POST-STERILE TEST DATA DEMONSTRATES THAT IT REQUIRES AN INFLATION VOLUME OF 24ML. MINIMUM TO CAUSE BALLOON JOINT TO DELAMINATE. ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT 763127 AND THIS THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. CURRENT INVESTIGATION DOES NOT INDICATE A MANUFACTURING DEFECT OR A TREND AT THIS TIME THEREFORE NO CORRECTIVE ACTION IS REQUIRED. HOWEVER 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 THEENDOPLEGE BALLOON RUPTURED. THE BALLOON WAS GIVEN TO HER BY THE OR STAFF AND THAT THE BALLOON WAS "DEFECTIVE AND LEAKING." NO OTHER INFORMATION IS AVAILABLE. NO PATIENT INJURIES WERE REPORTED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 763127

    Patients

    Seq Age Sex Outcome Treatment
    1