This is filed to report that the return device analysis found the steerable guide catheter cable broken.It was reported that this was a mitraclip procedure to treat mitral regurgitation.During preparation of the steerable guide catheter (sgc), functional testing failed as the knob would slip.When the + knob was turned, the guide turned back jerkily and the +/- knob did not move as usual.There was no patient involvement and no clinically significant delay in the procedure.Based on the return device analysis, a sgc cable break was noted.No additional information was provided.
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The device was investigated, and the returned device analysis confirmed the reported issue due to the observed broken ¿+¿ cable.A review of the lot history record identified no exception 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 a definitive cause for the observed cable break could not be determined in this complaint; however, the reported unintended movement was due to the cable break.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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