This is being filed to report the kink in the sgc tip.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.During advancement of the steerable guide catheter (sgc), resistance was met and the distal tip bent therefore the sgc was removed.The same issue occurred with the second sgc so the decision was made to use the left femoral access.One clip was 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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Return device analysis did not confirm the reported deformed sgc soft tip.However, a kink in the sgc braided shaft was observed.The reported failure to advance could not be replicated in a testing environment.A review of the lot history record identified no manufacturing nonconformities that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated, and the reported failure to advance appears to be due to challenging patient anatomy.The observed kinked sgc shaft appears to be a cascading event of the failure to advance.There is no indication of product issue with respect to manufacture, design or labeling.
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