This is being filed to report the leak.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced into the left atrium (la); however when the clip delivery system (cds) was inserted through the hemostatic valve, the water level in the sgc column dropped.After that, negative pressure was applied to fill the column with blood, and flush was performed with water.The hemostatic valve was confirmed to be working properly therefore the cds was reinserted however the water column dropped again.The sgc was replaced with a new one however the same issue occurred therefore the cds was replaced.The new cds was advanced without issue and the clip implanted, reducing mr to 1.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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All available information was investigated and the reported issue was not confirmed via returned device 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 other complaints reported from this lot.The investigation was unable to determine a cause for the reported leak (loss of fluid column).There is no indication of a product issue with respect to manufacture, design, or labeling.
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