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 81 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.
|
Reportable based on device analysis completed on 14-sep-2023.It was reported that the pump was damaged.The target lesion was located in the right iliofemoral vein.An angiojet solent omni was selected for use in thrombectomy procedure.During the thrombectomy procedure, after approximately 100 seconds, there was a rupture in the catheter connecting to the pump tip, rendering it unusable.The procedure was completed with another of the same device.The patient was stable and there were no patient complications reported.However, returned device analysis revealed a hypotube break.
|