(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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This report is filed as a leak was noted during device preparation.It was reported that during device preparation, while inserting the dilator into the steerable guide catheter (sgc), the dilator advanced too smoothly.There was no expected resistance at all.While flushing the sgc, the sgc lost the fluid column and air bubbles were noted in the hemostatic valve.Standard troubleshooting was performed, the stopcock was changed out, the sgc was re-flushed and aspirated.The hemostatic valve bubbles however remained.There was no patient involvement.The device was not used in a procedure.No additional information was provided regarding this device issue.
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Internal file number: (b)(4).Evaluation summary: all available information was investigated, and the reported issue of leaks and device operates differently than expected could not be confirmed via return device 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.In the absence of a confirmed failure modes a conclusive cause could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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