Device returned to manufacturer: visual inspection of the returned product (i.E., comet pressure guidewire connected to the optical cable connector, occ) was performed to assess any damage or irregularities associated with the tip, shaft, and sensor port.The device tip showed damage consistent with bending and stretched coils, as well as two kinks (167 and 167.5 cm from the tip).The device coating was also noted to be peeled at the 167.5 cm kink location.There was no body fluid residue noted in the sensor port.No other anomalies were noted with inspection of the remainder of the device.Functional testing was then performed.The occ handle was connected to the ffr link to verify signal strength; signal was present, confirmed via green lights per device design.The occ handle was then connected to bench top testing equipment and the guidewire was inserted in a pressure chamber.The pressure sensor appropriately responded to pressure increases and decreases as designed; coefficient values were consistent with programmed specifications.The occ handle was again connected to the ffr link and then the device was connected to polaris ilab test equipment via bluetooth.The comet guidewire communicated with the polaris system appropriately and zeroed as expected.The guidewire was inserted into the test pressure chamber and transferred a pressure waveform to the polaris system, indicating a functional guidewire.The guidewire was removed from the occ handle with no reported difficulty.Testing revealed that this device was functioning as intended.The observed damage was determined to be likely due to procedural and/or technique-related factors.
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