The site advised that the device is not available; therefore no evaluation of the graft was possible.Health effect: clinical code: (b)(4): no clinical signs/symptoms or conditions were reported.Health effect: impact code: (b)(4): this leakage event had no reported direct health consequence or impact for the patient.Medical device problem code: (b)(4): material integrity problem reported.Type of investigation: (b)(4): trend analysis: review of similar complaints of leakage for all gelsoft branded devices gave an occurrence rate of (b)(4).Type of investigation: (b)(4): communication/interviews: additional information was requested/received from the clinician regarding the procedure.This information confirmed that the clinician used the device as per ifu guidelines.Type of investigation: (b)(4): analysis of production records: 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.Type of investigation: (b)(4) device not returned: the site advised that the device is not available.Investigation findings: (b)(4): no device problem found: no issue was found with the manufacturing of the batch (based on the review of the retained production records).Investigation conclusions: (b)(4): cause not established: 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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