The tip, device shaft, sensor port, and the coefficient values were examined for damage, or any irregularities.The device showed 3 kinks located 160.5cm and 177cm from the tip, and at the occ handle.There was peeled coating at the 177cm location.The occ handle was connected to the ffr link to verify the signal strength.There were no issues in connecting to the ffr link.The signal was present, and showed green lights as designed.The occ handle was then connected to the bench top testing equipment, and the wire was inserted into the pressure chamber.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 values were 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 wire communicated to the polaris system, and zeroed as designed.With the wire inserted into the test pressure chamber, the wire transferred a pressure waveform to the polaris, which indicates a functioning wire.The wire was removed from the occ handle with no issues.The sensor port showed no residue of body fluids.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage, or irregularities.The complaint was not confirmed for pressure/signal issues.
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Reportable based on device analysis completed on 17sep2020.It was reported that a connection issue occurred.The target lesion was located in the left anterior descending artery.This comet pressure guidewire was prepped, but connection issues were noticed.The procedure was completed with a different device with no patient complications.However, device analysis revealed peeled coating.
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