A physician reported that the certas inlin valve (product id 828806) was implanted via v-p shunt (unknown date and setting).On an unknown date, underdrainage was found, and obstruction of the valve was suspected.Therefore, the valve was replaced with a new one.During the replacement, the patency of the ventricular catheter was confirmed, so the ventricular catheter remained, and the valve with the peritoneal catheter was replaced.After the procedure, it was confirmed that the distal side from the valve was obstructed.
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Unique device identifier (udi) : (b)(4).The valve and catheter were returned for evaluation.Failure analysis - the valve was visually inspected; a cut/torn was noted in the silicone housing just after the proximal connector and needle holes were also noted in the needle chamber.The position of the cam when valve was received was at setting 2.No occlusion and leakage noted in the catheter.The valve was hydrated.The valve was leak tested and failed, a leakage was noted from the cut/torn in the silicone housing just after the proximal connector.The valve was then pressure tested and failed the test due to the cut/torn in the silicone housing just after the proximal connector.The valve passed the test for programming, occlusion, refux and siphon guard.The root cause for the problem reported by the customer is due to the cut/torn in the silicone housing just after the proximal connector that was probably caused by a sharp or pointed object coming into contact with the silicone housing.As specified in the "ifu": "silicone has a low cut and tear resistance; therefore, exercise care when placing ligatures [.].Do not use sharp instruments when handling the silicone valve or catheters; use shod forceps.Cuts or abrasions from sharp instruments might rupture or tear the silicone components".
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