This is filed to report the inability to straighten the steerable guide catheter tip.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was prepared without issue per the instructions for use.The +/- knob was working fine.During groin insertion, the +/- knob was turned from 1/2 to 3/4 in the minus direction when a clicking noise was heard, the knob moved freely in the minus direction and the guide would not straightened anymore.The minus function was not working; however, the plus direction was still working.The sgc was exchanged for a new one and the procedure continued without further issue.1 clip was implanted reducing mr to grade <1.No adverse patient effects or a clinically significant delay in the procedure were reported.No additional information was provided.
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(b)(4).Evaluation summary: the device was returned and investigated.The reported mechanical issue was confirmed due to a broken cable, which resulted in the steerable guide catheter (sgc) unable to curve.The reported device operates differently than expected (noise) could not be replicated in a testing environment as it was likely a symptom of the cable break.A review of the lot history record revealed no manufacturing nonconformities reported to this lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigation and the reported sgc unable to curve guide and noise appear to be related to the broken cables; however, a conclusive cause for the cable break could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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