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 one kink located 38cm from the tip and the tip showed a bend.There was some peeled coating located at 172cm from the tip.The optical cable 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 port showed 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.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 on 9 oct 2019.It was reported that the comet pressure guidewire repeatedly encountered a drift in pressure values and also the torquer of the device became less effective.There were no patient issues.However, upon device return, it was noted that there was peeling of the coating of the comet.
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