On 04oct2023, (b)(6) provided an excel sheet with information about avi catheters that needed to be removed due to various malfunctions.One of these was a report of thrombus at a dwell time of one day.On 23oct2023, (b)(6) provided additional details: · the line was placed on (b)(6) 2023.The order stated that more access was needed.The patient received two doses of valproate.· doppler showed thrombus in the same vein as the hydromid from the proximal forearm to the distal clavicle and the line was removed on (b)(6) 2023.· lee noted that he's confident that the ifu was followed for proper care and maintenance during insertion, but he can't be sure about the level of maintenance after that unless he performs an audit.· no photos were taken, and the device was discarded by the user and therefore unavailable for return to avi for further investigation.The lot number provided (#11477925) is assigned by argon medical (avi's approved supplier for kitting).This kit contained catheters from two different avi catheter lot numbers: #03132301 and #04112303.For this investigation, both lhrs were reviewed.No nonconformances or deviations that could have contributed to the complaint issue were found.With the limited information provided and no return of the device, avi is unable to determine root cause.It is not known whether the hydromid device contributed to the reported thrombus.
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