A physician reported a certas valve was implanted in the patient via v-p shunt on an unknown date with unknown setting.Due to suspicion of obstruction, shunt imaging was performed on (b)(6) 2021, and ventricular enlargement was confirmed.The valve was removed and replaced on (b)(6) 2021.
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The certas valve was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; no defects noted.The valve was hydrated.The catheter was irrigated, no occlusions noted.The valve was leak tested and no leaks noted.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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