Exemption number e2019001.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 did not indicate a lot-specific quality issue.All available information was investigated and a definitive cause for the reported sgc leak (loss of fluid column) could not be determined.Based on the information reviewed, there is no indication of a product issue with respect to manufacture, design or labeling.
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This is filed for loss of fluid column.It was reported that during device preparation of the steerable guide catheter (sgc), a loss of fluid column was noted.Preparations per the instructions for use (ifu) steps were performed again, and the loss of fluid column was seen again.The decision was made to not use the device.There was no patient involvement and no reported clinically significant delay in the procedure.No additional information was provided.
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