Reportable based on device analysis completed on 07apr2023.It was reported that creases in the catheter occurred.An angiojet solent omni was selected for use in a thrombectomy procedure.During unpacking, creases in the mid part of the catheter were observed.The device was damaged and could not be used.During the procedure, the console worked normally.The procedure was completed with another of the same device.No patient complication were reported and the patient status was stable.However, returned device analysis revealed a broken hypotube.
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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 63 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.A pressure reading of 2.313 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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