This is filed to report a leak.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Prior to the procedure, it was noted that patient had a small atrium.The steerable guide catheter (sgc 00308u150) was advanced to the left atrium (la).The dilator and guide wire were removed, but it was noted the st-elevation had elevated and it was confirmed that air had entered the patient.No aspiration was performed, and the procedure was continued.No hemodynamic changes were observed; therefore, the clip introducer was inserted into the hemostatic valve of the sgc, but it was noticed that the sgc lost fluid column.The clip introducer was removed and reinserted, but the water level continued to drop; therefore, the sgc was removed.It was suspected that the hemostatic valve might not have been working properly.A new sgc (00308u246) was advanced, but after inserting the clip delivery system (cds), a loss of fluid column occurred.Aspiration was performed and the cds was removed.It was noted that the loss of fluid column may have been caused by insufficient closure of the hemostatic valve.The cds was reinserted and the sgc functioned as intended.The clip was successfully implanted, reducing mr to a grade of less than 1.After the procedure, the physician stated that no air was noticed in the left ventricle or aorta, so it was determined that the air had disappeared.The st-elevation was unable to be returned to normal.There was no clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported leaks and issue with the hemostasis valve.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.
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