(b)(4).No device problem found: review of device batch history records could find no issue with batch that would lead to issue reported during procedure.Cause not established: root cause of this event could not be established from information received or review of batch history records.This is the only event of this nature reported in last 5 years.A review of information received regarding the event was carried out by clinical risk and r&d departments and conclusion given was that this event is most likely related to coagulopathy / patient issue rather than device, it is unknown if the graft not being pre-soaked in saline or rifampicin/heparin prior to procedure as recommended in ifu contributed to this event.No graft was returned and no remaining grafts from batch were available for further investigation, therefore vascutek ltd.Now considers this complaint closed however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.
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