This is filed to report a damage soft tip.It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was attempted to be inserted but was unable to do so.The access point was dilated more and the sgc was again attempted to be inserted.However, it was observed the soft tip of the sgc was damage.Therefore, the sgc was not used and was replaced.Two clips were successfully deployed on the mitral valve, reducing mr to a grade of 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 reported damaged on the steerable guide catheter (sgc) soft tip was confirmed as it was observed to be deformed via returned device analysis.In addition, the reported difficult to insert in the anatomy could not be replicated in the testing environment as it is related to the procedural operational circumstances.A review of the lot history identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.Based on all available information, a cause for the reported difficult to insert cannot be determined.The damaged soft tip appears to be a cascading effect of the difficult to insert.There is no indication of a product issue with respect to manufacture, design, or labeling.
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