The device was not returned for analysis.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 incidents reported from this lot.All available information was investigated and a cause for the reported sgc leak could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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This is filed to report that during functional testing of the steerable guiding catheter (sgc), it was observed that the hemostatic valve didn't hold the water column.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr).During functional testing of the steerable guiding catheter (sgc), it was observed that the hemostatic valve didn't hold the water column.It seemed that the valve had a leak.A new sgc was used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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