Catalog Number 828814 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/13/2021 |
Event Type
Injury
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Event Description
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A physician reported a certas valve was implanted in a (b)(6)year-old male patient via v-p shunt in 2019 with unknown setting.The device was used with 823072 (serial; unk).On (b)(6) 2021, the set pressure was changed from setting 2 to 1 as the ventricles expanded, but the ventricles did not shrink.On december 20, obstruction was suspected, only the valve was removed and replaced.
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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N/a.
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Manufacturer Narrative
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The certas valve (id (b)(4)) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 1.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 occlusion issues were noted with the valve.
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Search Alerts/Recalls
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