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.A steerable guide catheter (sgc) was advancing but could not cross the septum.The septum was too small.Therefore, the sgc was removed and the septum was ballooned.The sgc was re-prepped; however, loss of fluid column was observed.The sgc was not re-introduced in the patient and the procedure continued with a new sgc.One clip was implanted, reducing mr to 2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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The returned device analysis could not replicate the reported failure to advance issue.The reported leak was confirmed based on the observed broken/damaged flush port luer.A review of the lot history record identified no exceptions issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The reported failure to advance appears to be due to user technique/procedural circumstance.Based on the information reviewed and the return device analysis, the reported leak was confirmed based on the observed broken/damaged flush port luer.The investigation determined the noted broken/damaged flush port luer appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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