This is being filed to report the cable break.It was reported that during preparation of the steerable guide catheter (sgc), when turning the + knob 90 degrees, the cable broke.The device was not used.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
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All available information was investigated, and the reported cable break issue was confirmed.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.All available information was investigated, and the cause of the reported break is undetermined.There is no indication of a product issue with respect to manufacture, design or labeling.
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