Visual analysis and additional testing were performed on the returned device.The imaging issue was unable to be confirmed due to the condition of the returned device (dried contrast within the sheath and catheter sheath damage) which prevented functional testing; however, the separation of the distal tip was able to be confirmed upon visual inspection.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot was performed and revealed there is no indication of a lot level quality product issue.The investigation was unable to determine a root cause for the reported imaging loss and tip separation.It is possible the reported loss of imaging was caused by either the patient anatomical condition(s) or a system issue; however, this could not be confirmed.The optical fiber of the catheter was confirmed to have remained intact.There was stretching in the window tube resulting in a separation of the distal tip of the catheter, which resulted in the distal edge of the guidewire exit notch being the most distal part of the returned device.The distal portion of the catheter separation was not returned and was most likely due to the use technique/angle of removal when the catheter was being removed from the guidewire once outside of the guide catheter.The separation would have likely occurred outside the patient or during post procedure handling/removal and was unrelated to the reported imaging issue.It should be noted that there were two successful pullbacks recorded on the returned device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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