Device evaluated by mfr: returned product consisted of a ffr comet pressure wire in one piece.Visual inspection of the device revealed that there was some slight bends in the wire which could be caused by normal use.Visual examination of the sensor port showed that the port did have some residual thrombus present.With the residual thrombus inside of the sensor port, this could potentially block the sensor from gathering a signal during the procedure and show an equalizing error like the one the customer witnessed.No other damage or irregularities were noticed.The pressure wire was connected to the analysis support test bench and all applicable data was correct as designed, there was no difficulty in connecting the wire.The coefficient was confirmed to be in specification.The manufacturing batch record review confirmed the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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