The device was not returned for analysis.A review of the lot history record identified 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 definitive cause for the reported leak in this incident could not be determined.It is possible that the user technique during device preparation contributed to the reported leak; however, based on the reported information and without the device to analyze, this cannot be confirmed.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.
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This report is submitted because during preparation of the steerable guiding catheter (sgc), the sgc failed to hold column (air leak).If this were to recur in the anatomy, there's potential of air embolism.It was reported that during preparation of the steerable guiding catheter (sgc) the hemostatic valve could not hold the fluid column (air leak).There was no patient involvement and the device was not used in anatomy.There was no clinically significant delay to the intended procedure.No additional information was provided regarding the sgc issue.
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