This is filed to report leak and medical intervention.
It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4+.
It was noted thickened and restricted leaflets.
The first steerable guide catheter (sgc 10514r223) was advanced to the mitral valve; however, the guide lost column and air entered the sgc.
One aspiration was performed to remove the air from the column and the sgc was safely removed.
Air did not enter the patient, a second sgc (10625r222) was being prepared; however, when the dilator was advancing into the sgc, the guide would not hold column.
The sgc was not used in the patient.
The procedure continued with a third sgc.
The sgc was advanced to the mitral valve, and one clip was deployed without issue.
The clip then became detached from detached from the anterior leaflet, but remained attached to the posterior leaflet (single leaflet device attachment/slda).
Therefore, a second clip was deployed to stabilize the slda and further reduce mr.
Two clips were implanted, reducing mr to 1.
There were no adverse patient effects and no reported clinically significant delay in the procedure.
No additional information was provided.
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