Device returned to manufacturer: the tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The device showed two kinks located 120cm and 152cm from the tip.The tip showed bend damage and stretched coils.There was peeled coating located 152cm location.The occ cable was connected to the ffr link for signal verification.The signal was not present as designed.Device analysis was conducted by inspecting the proximal end of the wire for any damage to the fiber optic.No damage was noticed.The sensor was inspected by viewing the sensor port to verify that the sensor was in the correct location.This sensor looked to be too far distal which would give the indication of the sensor being detached from the fiber optic cable.The wire was gently shaken to see if the sensor would move within the sensor housing and the sensor did move which verifies the sensor was detached from the fiber optic.The coefficient values were confirmed to be programmed per document ((b)(4)).The wire was removed from the occ handle with no issues.Inspection of the remainder of the device, apart from the observed damage revealed no damage or irregularities.Device analysis determined the condition of the returned device was consistent with the reported information of a damage/defective issue with the wire.
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