The reported leak / splash during procedure could not be replicated in a testing environment due to the returned condition (only the ci was returned and the cds was not returned).Additionally, the silicone valve inside the clip introducer (ci) was observed to be torn.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.All available information was investigated, and the reported leak appears to be related to the observed tear in the silicone valve inside the clip introducer; however, how the silicone valve got torn cannot be determined.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was inserted without issues, but when inserting the clip delivery system (cds), air was observed in the hemostasis valve of the sgc.Aspiration was performed, but the issue continued to occur.Therefore, the sgc was removed and replaced.A new sgc was inserted, but the same issue occurred.The physician stated the leak was caused by the clip introducer (ci) of the cds.Therefore, the ci was replaced and the issue was resolved.Two clips were then implanted, reducing mr to a grade of 2.There was no clinically significant delay in the procedure.
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