(b)(6).Device evaluated by mfr.: returned product consisted of an angiojet solent omni catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed multiple bends and kinks.Functional testing was attempted; however, the device would not prime.During analysis at the severely kinked location at 1 cm from the tip, the hypotube was broken and completely separated.The device could not be functionally tested due to the extreme damage on the device.No pressure reading was reported before the console would stop the priming process and issue an under-pressure alarm.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for under pressure issues related to a broken hypotube.Kinks were also confirmed.
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Reportable based on device analysis completed on 27-jul-2023.It was reported that an error and pump boot leak occurred.The target location was located in the lower limb vein.An angiojet solent omni was used for thrombectomy procedure.During the procedure, it was noted that the system alerted an error, and the pump boot was leaking.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed a broken hypotube.
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