This follow-up report is submitted to the fda in accord with applicable regulations.Visual inspection was performed on the returned sample, during which no anomalies were noted, other than dried blood within the valve.Ops valves are subject to a 100% leak test, which includes five different tests the units are run through to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.The returned sample was manually run through each of these tests to determine if the umbrellas were functioning properly; all tests passed.A retention sample from the same product code/lot number combination was run through the same tests and confirmed to pass each of the 5 leak tests.Simulation testing of the ops valve in an aortic root vent line found the ops valve to leak if the vent line was not properly clamped during cardioplegia delivery, and there was possible pressure buildup in the heart causing a positive pressure buildup in the vent line.The positive pressure relief valve then opened to release the pressure, and cause the ops valve to leak.This may have been the cause of the reported leak if the valve was used in the aortic root vent line.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
|