This is filed to report the steerable guiding catheter (sgc) shaft break.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with an mr grade of 4.The steerable guiding catheter (sgc), could not be inserted into the inguinal region and the distal shaft broke, kinked and bent after several attempts.The inguinal region was dilated with a balloon and a new sgc was used without further issue.One clip was implanted, reducing mr to 1.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation determined the reported difficulty inserting the device appears to be related to morphology/pathology.The reported broken and kinked shaft were results of the difficulty inserting.There is no indication of a product issue with respect to manufacture, design or labeling.
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