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).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.Based on the information provided and analysis of the returned device, the reported imaging loss was due to operational context.It is likely that the observed optical fiber break caused the reported loss of imaging.It could also be that the patient¿s anatomical condition(s) or the use technique(s) employed by the user caused the observed optical fiber damage; however, this information could not be confirmed.There was a tear of the distal edge of the guidewire exit notch which progressed distally and was likely due to the use technique/angle when the device was removed from the guidewire.The tear would have likely occurred outside the patient and during post procedure handling/removal and was unrelated to the reported imaging issue and observed optical fiber break.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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