Device returned to manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of a 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 shaft showed 2 kinks located 156.5cm from the tip and at the occ handle.The tip showed stretched coils.There was peeled coating at the 156.5cm location.The occ handle was connected to the ffr link to verify the signal strength.The signal was present and showed green lights as designed.The wire was inserted into the pressure chamber test equipment and the pressure was increased to verify the sensor was indeed reacting to the pressure increases and decreases.The pressure sensor functioned as designed.The coefficient was confirmed to be programmed.The occ handle was again connected to the ffr link.The device was then connected to the polaris (ilab) test equipment via bluetooth signal.The ffr link and wire communicated to the polaris system and zeroed as designed.With the wire inserted into the test pressure chamber, the wire transferred a pd pressure waveform to the polaris which indicates a functioning wire.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The occ handle cap was loosened to remove the wire.There was no issue with removing the wire.The sensor housing showed no residue of body fluids.Device analysis determined the condition of the returned device was not consistent with the reported information.
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