A physician reported a hakim valve was implanted in a (b)(6) male patient due to inph (idiopathic normal pressure hydrocephalus) via l-p shunt in (b)(6) 2015 with unknown setting.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).In (b)(6) 2022, the patient visited the hospital because of gait disturbance and some dementia.Shunt imaging was performed, and ventricular enlargement was observed.The set pressure was changed, but the symptoms did not improve.The valve was removed and replaced on (b)(6), 2022.
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The hakim valve ((b)(4)) was returned for evaluation.Device history record (dhr) - the product code (b)(4) with lot crpblb, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; needle holes in the needle chamber were noted.The position of the cam when valve was received was 90mmh2o.The valve was hydrated.The catheter was irrigated no occlusions noted.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 no functional issues were noted.
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