This is filed to report leak and medical intervention it was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3+.The first steerable guide catheter (sgc 01006u247) was advanced to the mitral valve; however, the dilator lost fluid column after dilator removal.Therefore, additional aspirations were performed and the sgc was removed.A second sgc (00822u211) was advanced to the mitral valve; however, the second sgc also lost fluid column after dilator removal.Additional aspirations were performed.A new sgc was not available, and therefore a decision was made to exchange the dilator for the second sgc.The sgc was successfully used and air never entered the patient.One clip was implanted, reducing mr to less than 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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All available information was investigated and the loss of fluid column (leak) could not be 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 loss of fluid column (leak).The additional therapy/non-surgical treatment was a result of case specific circumstances as additional aspiration was performed.There is no indication of a product issue with respect to manufacture, design, or labeling.
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