Initial reporter address 1: (b)(6).Device returned to manufacturer: the comet pressure guidewire was returned and analysis was completed.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The shaft showed two kinks located 33cm and 177cm from the tip.The shaft showed peeled coating at the 177cm location.The device handle was connected to the ffr link for signal verification.The signal was present as designed.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.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 in specification.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
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Reportable based on analysis completed 22 nov 2019.It was reported that a recognition error occurred.This comet pressure guidewire was selected; however, a device recognition error occurred.The procedure was completed with a different device.There were no patient complications reported.However, the returned device analysis revealed some slight peeling of the device coating.
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