Device evaluated by mfr: the returned product consisted of an ffr comet pressure wire connected to the occ cable.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The device showed 1 kink located 175.5cm from the tip.There was peeled coating located at the 175.5cm 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 specification.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 other damage.Device analysis determined the condition of the returned device was consistent with the reported information of a pressure/signal issue with the wire.
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Reportable based on device analysis completed on 16jul2020.It was reported that a connection issue occurred.The target lesion located in the mildly stenosed and mildly calcified lesion.This comet pressure wire was selected, during preparation a connection issues were noticed outside the patient.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.However, device analysis revealed peeled coating.
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