BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 1934733 · Received December 21, 2010

    Report

    Report Number
    3008500478-2010-00042
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 19, 2010
    Report Date
    February 4, 2011
    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

    EVALUATIONS RESULTS; ORIGINALLY, AN INTERLUMEN LEAKAGE WAS OBSERVED IN THE INITIAL EVALUATION. HOWEVER, PER THE MANUFACTURER ON (B)(6) 2011 THIS DEVICE WAS RE-EVALUATED AND PROPERLY CLAMPED. THERE WAS NO INTERLUMEN LEAKAGE. AIR WAS INTRODUCED THROUGH THE DEVICE BALLOON AND THERE IS DELAMINATION OF THE DISTAL BALLOON BOND. COLORED WATER WAS INTRODUCED INTO THE DEVICE BALLOON AND THERE IS A FLUID PATH WHERE THE DISTAL BALLOON BOND HAS DELAMINATED. WATER WAS INTRODUCED THROUGH ALL OF THE DEVICE LUMENS AND WHEN WATER WAS INTRODUCED INTO THE PRESSURE LUMEN THE WATER CAME OUT OF THE DEVICE DISTAL TIP. THE DISTAL END OF THE DEVICE WAS CLAMPED OFF AND THE DEVICE WAS TESTED FOR INTERLUMEN LEAKAGE AND THERE IS NO INTERLUMEN LEAKAGE 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 6ML. MINIMUM TO CAUSE BALLOON JOINT TO DELAMINATE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT 774334 AND THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS DELAMINATED BALLOON BOND ON THE ENDOPLEGE AND IS APPLICABLE TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    SERIOUS INJURY DUE TO DEVICE BEING SWITCHED DURING USE FOR A NEW ONE. EVALUATION RESULTS: UNIT IS SENT TO ACCELLENT FOR EVALUATION (B)(6) 2010-ACCELLENT EVALUATION-AIR WAS INTRODUCED THROUGH THE DEVICE BALLOON AND THERE IS DELAMINATION OF THE DISTAL BALLOON BOND. COLORED WATER WAS INTRODUCED INTO THE DEVICE BALLOON AND THERE IS A FLUID PATH WHERE THE DISTAL BALLOON BOND HAS DELAMINATED. WATER WAS INTRODUCED THROUGH ALL OF THE DEVICE LUMENS AND WHEN WATER WAS INTRODUCED INTO THE PRESSURE LUMEN THE WATER CAME OUT OF THE DEVICE DISTAL TIP. THE DISTAL END OF THE DEVICE WAS CLAMPED OFF AND THE DEVICE WAS TESTED FOR INTERLUMEN LEAKAGE. THERE IS INTERLUMEN LEAKAGE BETWEEN THE INFUSION AND PRESSURE LUMENS. VISUALLY THE DEVICE HAS NO OTHER DEFECTS. A REVIEW OF POST-STERILE TEST DATA DEMONSTRATES THAT IT REQUIRES AN INFLATION VOLUME OF 6ML. MINIMUM TO CAUSE BALLOON JOINT TO DELAMINATE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT_ AND THIS THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. NO CORRECTIVE ACTION IS BEING PURSUED AT THIS TIME 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 WHEN THE BALLOON WAS INFLATED THE VOLUME WENT OUT THE TIP. THE DEVICE HAD TO BE SWITCHED OUT FOR ANOTHER DURING USE. DR. (B)(6) WAS THE ANESTHESIOLOGIST AND HE SAID HE THOUGHT IT MAY BE GOING OUT OF THE LUMEN SOMEWHERE AND THE FLUID IS BEING LOST BEFORE IT GETS INTO THE BALLOON OR IT MAY BE THE BALLOON JUST ISN'T MAINTAINING THE VOLUME, POSSIBLE LEAK. NO ADVERSE PATIENT EVENTS, 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 774334

    Patients

    Seq Age Sex Outcome Treatment
    1 Other