The 4fc12 sheath with lot 0010160354 was returned and analyzed.Visual inspection of the sheath showed that the shaft was kinked and twisted 2.5 inches from the tip.It was impossible to insert the test balloon catheter into the sheath and deflection did not work as expected due to the kink.In conclusion, the reported kink was confirmed through testing.The sheath failed the returned product inspection due to a shaft kink and twist.If information is provided in the future, a supplemental report will be issued.
|