E1: initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the product was returned to boston scientific for analysis.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 57 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 the device analysis completed on 16aug2023.It was reported that error message occurred.The 70% stenosed target lesion was located in the non-tortuous and severely calcified acute dvt in the left lower limb.An angiojet solent omni was used for thrombectomy procedure.However, while carrying out the procedure, the device indicated a saline error and detected a leakage of liquid at the point where the non-return valve is connected.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed a hypotube break.
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