Device evaluated by mfr: returned product consisted of a solent dista thrombectomy.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.There was fluid in the attached waste bag, when received.There were numerous kinks throughout the device.Functional testing was performed by placing the device in the angiojet console.The complaint device failed to prime and the "check catheter for kinks" error was displayed on the console, meaning that the device over-pressured.The over-pressure alarm was overridden on the console and the device was ran through the prime and thrombectomy mode.The device ran at a high-pressure; however, the device didn't leak.The device was removed from the console and the shaft was inspected again, but there were no kinks severe enough or reason that would have caused an over-pressure alarm.The shaft and tip were cut and the jets were microscopically inspected and it was revealed that a jet was plugged, causing the over pressure as the flow was being restricted.Further analysis revealed the obstructed jet hole was plugged with gold, which the jet body material is made of.Inspection of the remainder of the device revealed no damage or other irregularities.
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Reportable based on device analysis completed on 12jun2019.It was reported that an error message occurred during device preparation.An angiojet solent dista catheter was selected for a thrombectomy procedure.During preparation, a "check saline supply error" message occurred.The device did not enter the patient's body.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed a clogged jethole.
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