Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
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This is filed to report a leak.It was reported that during preparation, the leakage test of the hemostatic valve was performed, but it was noted that air entered the system and a loss of fluid column occurred.The air entered as soon as the finger was away from the tip of the steerable guide catheter (sgc), which caused the fluid level to drop.The system was tested three times, as well as the threeway stopcock, and fluid dropped each time.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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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 the reported event.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 loss of fluid column in this incident could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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