BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 2129076 · Received June 16, 2011

    Report

    Report Number
    3008500478-2011-00110
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION:THE DEVICE BALLOON WAS VISUALLY INSPECTED UNDER 10X MAGNIFICATION AND IT IS NOTED THAT THE BALLOON HAS BURST. VISUALLY THE EDGES OF THE BURST ARE SMOOTH AND THERE IS EVEN THICKNESS IN THE AREA THAT BURST. ONE OF THE EDGES OF THE BURST APPEARS TO HAVE A SMALL RADIUS WHICH IS CONSISTENT WITH A SHARP OBJECT HITTING AN INFLATED BALLOON. VISUALLY THE DEVICE IS STILL INSIDE OF THE INTRODUCER AND THE DEVICE IS KINKED. THE DEVICE WAS REMOVED FROM THE INTRODUCER AND THE CONTAMINATION GUARD WAS CUT OFF OF THE DEVICE TO EXPOSE THE SHAFT FOR VISUAL INSPECTION. VISUALLY THERE IS A SHARP KINK APPROX 4.5 INCHES FROM THE PROXIMAL STRAIN RELIEF. VISUALLY THERE IS ALSO A SHARP KINK JUST DISTAL TO THE 3CM MARKER. VISUALLY THERE ARE TWO MORE SHARP KINKS ONE IS JUST DISTAL TO THE 2CM MARKER AND THE OTHER IS APPROX. 2.5 INCHES FROM THE DISTAL TIP. WATER WAS INTRODUCED THROUGH ALL OF THE DEVICE LUMENS AND THE WATER FLOWS FROM WHERE IT SHOULD HOWEVER IT TOOK MORE PRESSURE ON THE SYRINGE TO INTRODUCE THE WATER BECAUSE THE SHARP KINKS MAKE IT DIFFICULT. THERE ARE NO OTHER DEFECTS DETECTED WITH THIS DEVICE. THESE DEVICES ARE VISUALLY AND FUNCTIONALLY TESTED 100% PRIOR TO PACKAGING. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT 841434 AND THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. ROOT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE BALLOON BURST WAS THE RESULT OF A NEEDLE STICK AND COULD BE A USE ERROR THEREFORE NO CAPA REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE MD: A (B)(6) PATIENT WITH VERY COMPLEX MITRAL CASE DONE WITH ENDOCLAMP, WHERE THE CSC (ENDOPLEGE CORONARY SINUS CATHETER) BALLOON RUPTURED AT THE END OF THE CASE. WE WERE DELIVERING OUR LAST RETROGRADE CARDIOPLEGIA DOSE. THIS ONE LOOKS LIKE IT LITERALLY EXPLODED. BALLOON VOLUME WAS 0.4 ML. IT WAS A UNUSUALLY LONG METAL CASE. THE RETROGRADE PRESSURE AND FLOW WAS GOOD THROUGHOUT THE CASE UNTIL THE WE STARTED GIVE WARM BLOOD CARDIOPLEGIA @,37*C. NOW THIS WAS THE SECOND TIME WE GAVE THE REWARMING CARDIOPLEGIA, WHEN THE BALLOON BURSTED. I DID SEE A RISE IN THE PRESSURE ( ABOUT 25MMHG), AND NOTICE IT WAS LOW AND A CONSTANT LOW PRESSURE, WHICH UPON CHECKING SAW THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CORONARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 841434

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR