BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEDGE CORONARY SINUS CATHETER

    MDR report key: 1981764 · Received February 8, 2011

    Report

    Report Number
    3008500478-2011-00047
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 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

    ON 2/4/2011: EVALUATION: THE BALLOON WAS ASPIRATED TWICE THEN INFLATED WITH 2CC OF COLORED WATER. VISUALLY THERE IS DELAMINATION OF THE DISTAL BALLOON BOND AND THERE IS A FLUID PATH WERE THE BOND DELAMINATED. WATER WAS INTRODUCED THROUGH THE PRESSURE AND INFUSION LUMENS AND THE WATER FLOWS FROM WHERE IT SHOULD. VISUALLY THERE IS A KINK IN THE BELLOWS, HOWEVER, THIS DOES NOT AFFECT THE WAY THE DEVICE FUNCTIONS. THERE ARE NO OTHER DEFECTS DETECTED WITH THIS DEVICE. A CORRECTIVE ACTION WAS CREATED TO DETERMINE ROOT CAUSE OF THE DISTAL BALLOON BOND DELAMINATION AND IS APPLICABLE TO THIS EVENT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT 774333 AND THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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 THE DURING A ROBOTIC MVR CASE, THE ANESTHESIOLOGIST PLACED THE EP UNDER TEE AND ALL LOOKED WELL. HE HAD VENTRICULARIZATION WITH 1/2 CC OF VOLUME. HE NOTICED THAT HE LOST THE WAVEFORM PRIOR TO PLACING THE PACING SWAN. WHEN HE WITHDREW ON THE BALLOON SYRINGE, HE DID NOT GET THE VOLUME BACK OUT, HOWEVER, NO BLOOD CAME BACK EITHER. HE DID NOT GET VENTRICULARIZATION BACK WITH ADDITIONAL VOLUME. HE REMOVED THE EP AND AFTER FURTHER EVAL SAW THAT THE BALLOON WAS NOT HOLDING VOLUME DUE TO SMALL HOLE. HE PLACED ANOTHER EP AND CASE WENT ACCORDING TO PLAN. DR (B)(6) WAS THE ANESTHESIOLOGIST AND DR (B)(6) WAS THE SURGEON. NO PROLONGED OPERATING ROOM TIME. NO ADVERSE PATIENT EVENTS. SEND RESPONSE LETTERS TO REP. UPDATE (B)(6) 2011: PER SALES REP: EDWARDS INTRODUCER WHICH WAS SUPPLIED WITH THE EP WAS NOT USED IN THIS CASE. SWITCHING OUT THE EP DEVICE DURING USE DID NOT INTERRUPT CARDIOPLEGIA DELIVERY OR CARDIOPULMONARY BYPASS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1