Visual and dimensional analysis was performed on the returned device.The reported connection issue and gas leak was unable to be confirmed due to the condition of the returned device.However, the rfid (radio frequency identification device) chip was read which revealed that the catheter had been successfully connected to the system.Additionally, an optical fiber test revealed an optical fiber fracture in the window region of the catheter.Dimensional analysis confirmed that the purge hole was within specification.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 identified no other similar complaints reported from this lot.Based on the information received and analysis of the returned device, the investigation was not able to determine a definitive cause for the reported communication or transmission problem or gas leak.It may be possible that, during device preparation, the syringe was pulled instead of pushed causing air to flow from the x-ring retainer into the syringe.However, due to the dried contrast, this could not be confirmed.Furthermore, it may be possible that during use, the device was inadvertently damaged causing the noted optical fiber fracture in the window region resulting in the reported communication failure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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