A physician reported that the certas valve was implanted to a (b)(6) old female patient on (b)(6) 2020.Three months post operative the patient returned to the hospital because a pseudomeningocele was developing around the implant site and was sent for a ct.The ct indicated fluid collection and a potential distal catheter disconnection.The patient was taken to the or for a revision.When the site was examined, the surgeon discovered that the housing of the valve had split at the point where the siphonguard connects to the valve housing.The distal catheter was connected and intact.The valve was then replaced, and surgery was completed.The patient was transferred to the floor and released.The patient is currently stable.
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Updated fields: d10, g4, g7,h2, h3, h6, h10.The valve was returned for evaluation.Failure analysis the valve was visually inspected; a cut/tear was noted in the silicone housing around the siphon guard complaint confirmed.The siphon guard was visually inspected and marks were noted in the siphon guard.The root cause for the housing of the valve had split at the point where the siphonguard connects to the valve reported by the customer is due to a sharp or pointed object coming into contact with the silicone housing, as noted in the ifu silicone has a low cut/tear resistance.The root cause for the marks found in the siphon guard would be due to a sharp or pointed object coming into contact with the siphon guard.
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