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Health effect: clinical code: (b)(4): no clinical signs, symptoms or conditions - no health consequences for the patient.Health effect: impact code: (b)(4): no health consequences or impact - no patient harm or consequence: leak suture during procedure.No significant blood loss or delay to procedure.Medical device problem codes (b)(4): material integrity problem: site reported hole at bifurcation appeared during procedure.(b)(4): material puncture / hole: hole reported near to the bifurcation site of device component code: (b)(4): term not applicable: the gelsoft bifurcate does not contain any additional parts or subassemblies.Type of investigation codes: (b)(4): analysis of production records: a review of the retained manufacturing and quality control records confirmed that this batch was manufactured to the intended specifications.Specific emphasis was directed toward the porosity testing results, which clearly indicate good results in the lower end of the test.(b)(4) communication / interviews.Further information was provided by site - graft did not receive any excessive manipulation prior to/during use.It was reported that the graft was not presoaked in saline or other fluid based solutions prior to use/ for 5 minutes as recommended by the included ifu booklet to improve handling and to make the device less susceptible to leakage.However the clinician did indicate that the graft was briefly primed with saline after it was implanted and prior to blood release through the graft.(b)(4): trend analysis: a review of similar events for gelsoft branded devices provided an occurrence rate of (b)(4) (complaint v sales).No reports of leakage has been received for any of the remaining grafts from this batch.(b)(4): device not accessible for testing - device remains in situ and was not explanted.Investigation findings: (b)(4): no device problem found - no issue was found with the review of batch records that could have resulted in leakage reported.Investigation conclusion (b)(4): no problem detected: no issue was found with manufacture qc or physical testing of batch.(b)(4): unintended use error caused or contributed to event: the device was not pre-soaked as per ifu recommendation prior to use and this may have contributed to the event.As no device will be returned for further investigation as it remains implanted vascutek ltd now considers this complaint 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 and if an adverse trend develops action may be taken at that time.
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