Device evaluated by mfr.: 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 clearly 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.
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Reportable based on device analysis completed on 17-november-2022.It was reported that tip damage occurred.An angiojet avx catheter was used for graft fistula procedure.Upon removal of the catheter, they noticed it was mangled along the tip.The procedure was completed with this device.No patient complications reported, and the patient's status was okay.However, device analysis revealed a broken hypotube.
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