This is filed to report a cable break and positioning failure.It was reported that during preparation of the steerable guide catheter (sgc), the +/- knob was turned, but the device did not straighten.It was suspected a cable break occurred.Therefore, the sgc was not used and was replaced.There was no clinically significant delay in 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 that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information and without the device to analyze, the cause of the reported positioning failure (straighten ¿ unable), and the conservatively reported break (cable break), could not be determined as there were no reported issues during device preparation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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