A physician reported a certas valve was implanted to a (b)(6) male patient via lumbar peritoneal shunt on (b)(6) 2021 with setting 7.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).In may, the patient went to the hospital because of being ill.There was no problem with "adl" etc., but the pressure setting was changed to 6.The patient returned to the hospital in july.Since neither contrast enhancement nor flushing was possible, the shunt was removed and replaced on september 8 after follow-up.
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Updated fields: d4, d9, g3, g6, h2, h3, h6, h10 the certas valve was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 5.The valve was visually inspected; needle holes in the needle chamber were noted.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation the no functional issues were noted with the valve.
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