We have not received the device for evaluation since the device remains implanted in the patient.A visual inspection performed on this exact patch on december 22, 2017 passed all the qc requirement.The inspection ensured that the patch was smooth, collagen was evenly impregnated throughout the graft, and there were no holes, broken threads or any loose fibers in the patch.Another released patch from our inventory from the same lot number ( serial (b)(4) lot# 204574) was also visually inspected.We did not find any defect with this patch.The collagen was evenly distributed throughout the patch.No pinhole was detected in this patch.As part of our investigation, we conducted a lot history records review for this product, which did not reveal any discrepancies during the manufacturing processes that could be related to the complaint event.All of the quality control tests passed with expected values.Specifically, the physical incubation test (which measures how well the collagen was cross-linked), water permeability, and puncture test performed on a portion of the same exact graft demonstrated that the grafts from this lot performed as expected at the time of release.(b)(4) albosure patches were manufactured under this lot number.(b)(4) units have been sold.We have not received any other complaints of a similar incident related to this lot number.At this time, we are inconclusive about the root cause of the incident.The hole in the patch led to a prolonged haemostasis.The hole was sewed using a 6-0 suture.
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