It was reported that an edwards retrograde catheter did not function during a case.Through further investigation, it was learned that the catheter would not advance into the coronary sinus and kinking was noted.The catheter was in the coronary sinus opening and perfectly lined up.Advancement of the catheter would only result in the catheter looping toward the tricuspid valve and not advancing further into the coronary sinus.The device was already on maximal antegrade flexion.Three attempts were made and each time the coronary sinus was successfully engaged; however, the surgical team was unable to occlude and perform a venogram.The catheter was removed and the procedure proceeded with standard cardioplegia.There was no visible kinks on the device after removal.The patient did not sustain any injury due to this event.
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Device evaluated by manufacturer: as received, there was no visible evidence of a kink found on the device and the device articulated normally.Patency test was performed on all lumens and no leaks or occlusions were found.The balloon was tested and functioned without issues.There was no other visual damage, contamination, or other abnormality found on the device.Based on the product evaluation findings, a product deficiency was not identified.Operational context most likely contributed to this event.The instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The ifu provides the following warnings: i"f resistance is met, stop and re-evaluate proplege device position.The proplege device should not be advanced if resistance is felt, as doing so would cause the proplege device to bend or buckle.Aggressive advancement in an attempt to engage the ostium may result in perforation or other injury.Continuously monitor the pressure at the tip of the catheter.A pressure change that indicates the catheter has entered the right ventricle should be noted.Do not advance the catheter further if the tip is in the right ventricle as perforation or other injury can occur.The catheter should not be advanced when the tip is in the right ventricle.Additional fluoroscopic views may provide further information concerning catheter position (e.G.30° rao, 30° lao).Recommended for use with a water soluble contrast medium intended and approved for venography."no further corrective or preventative actions are required at this time.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.
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