Date of event: used the first day of the month of the aware date as no exact date provided.Device evaluated by mfr.: returned product consisted of the catheter portion of the zelantedvt thrombectomy system.The effluent and supply lines were cut-off at the hub and the effluent/supply lines, and the pump assembly were not returned for analysis.The shaft and tip were microscopically and visually inspected.Blood was present outside and inside the device, when received.Inspection of the device revealed that the transition between the proximal and outer shafts was separated (10.5cm proximal of the tip).The separated ends were jagged, indicating that there was force applied before the separation.The hypotube from the proximal and outer shaft transition to the proximal marker band was twisted with the hypotube detached from the jet body.The shaft was buckled at the distal window and markerband.The proximal markerband and shaft were cut to check the proximal saddle and hypotube at the saddle.When the shaft was removed and the hypotube and saddle inspected, there was no damage or irregularities.Functional testing could not be performed, as the catheter was cut-off from the proximal portion of the device with the pump assembly; however, it is known that when the hypotube is detached the device will not prime and the console will continue to try and prime the catheter, causing the "check saline supply" error to display on the console.
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Reportable based on device analysis completed on 20dec2019.It was reported that an error message occurred.An angiojet zelantedvt was advanced for a thrombectomy procedure.However, it was noted that an error message occurred.No patient complications were reported.However, returned device analysis revealed a hypotube detached/separated.
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