This is filed to report a cable break.It was reported that the patient underwent a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.Challenging anatomy included a medial commissural flail, tortuous vein, and a superior transseptal stick to get enough height above mitral valve.The steerable guide catheter (sgc) was advanced in the patient.It was noted that an extreme amount of plus (+) knob was used.While turning the plus (+) knob almost a full turn the cable broke.The sgc was removed from the patient and a new one was used to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.
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All available information was investigated, and the reported cable break was 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 similar complaints reported from this lot.Based on available information, a cause for the reported cable break cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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