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 83.5 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.
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Reportable based on the device analysis completed on 07apr2023.It was reported that the barcode could not be read.The target lesion was located in the left lower extremity.An angiojet solent omni was selected for a thrombectomy procedure.During preparation, the catheter was connected and the bar code was unreadable.The procedure was completed with a different device.There were no patient complications and the patient status is stable.However, device analysis revealed a broken hypotube.
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