Visual analysis was performed on the returned device.The reported communication or transmission problem was unable to be confirmed due to the condition of the returned unit.Functional testing could not be performed as the pressurewire corewire, and microcables were separated 39 cm distal to the proximal tip.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other similar complaints reported from this lot.Based on the reported information and analysis of the returned pressurewire, the reported connection issue appears to be due to operational context.It is likely that during use, damage to the microcables occurred due to a kink resulting in the reported communication problem.The noted separations likely occurred at the kink due to post-use handling/packaging the device for return.It was determined that the pressurewire was used after expiration of 4/30/2022.The procedure date was (b)(6) 2023; therefore, the device was used approximately 19 months after expiration.The pressurewire instructions for use (ifu) references the ¿use by¿ date symbol which is available on the product label to indicate the product expiration date.The expiration date of the product is important for the sterility, efficacy, and performance of the device.In this case, it could not be determined if the reported event was a result of the product being used past the expiration date.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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