Device evaluated by mfr.: returned product consisted of a solent dista thrombectomy in two pieces.The pump, effluent/supply line, shaft, tip, piston, and spike line were microscopically and visually inspected.There was blood present in the device.Inspection of the device revealed that the shaft was detached 59cm distal of the strain relief.The shaft appeared to have been kinked/bent prior to separation.With the shaft separated, the hypotube would also be separated in the same location.When the hypotube is broken, the device will not prime and the console will continue to try and prime the catheter.This will cause the 'check saline supply' error to display on the console and the device not to prime.
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Reportable based on device analysis completed on 21-feb-2020.It was reported that device displays error message.After two angiojet solent dista catheters were used but failed the priming process, another catheter was advanced for a thrombectomy procedure.After the catheter was successfully primed, the catheter was put over the unknown wire and was introduced into the patient.However, the catheter would not function and check saline supply error occurred.The physician ended up infusing the patient overnight with a non-bsc device and going to look at it again the next day.No patient complications were reported.However, device analysis revealed a hypotube and shaft detachment/separation.
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