The returned valve was patent.The valve met the requirements for valve flux, siphon, reflux, preimplantation, and pressure-flow testing.It did not meet the requirements for leak testing.The valve did not meet the requirements for leak testing due to tears/cuts on the casing of the delta chamber.Damage was also observed on the side of the delta chamber.It is unknown how or when this damage occurred.The ifu cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity¿¿ particulates/debris were also observed in the valve.It is unknown how or when these particulates/debris entered the valve.The ifu cautions, ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handling.Introduction of contaminants could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion¿¿ all valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
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