The site advised that the device is not available; therefore no evaluation of the graft was possible.(b)(4).Review of similar complaints of leakage for all gelsoft branded devices gave an occurrence rate of b4.Additional information was requested from the clinician regarding the procedure.A review of the retained qc and manufacturing records for this batch (with attention to all in process and base material porosity testing) confirmed that the batch was manufactured to its design specification.The site advised that the device is not available.No issue was found with the manufacturing of the batch (based on the review of the retained production records).The root cause of the reported defect could not be determined.Vascutek ltd.Considers this event as closed.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process, if an adverse trend develops action may be taken at that time.
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