Catalog Number 823074 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/06/2021 |
Event Type
Injury
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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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1 of 2 reports.Other mfg report number: 3013886523-2021-00564.A physician reported a certas valve was implanted via l-p shunt on (b)(6) 2021 with unknown setting.The valve was used with 823074 and the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).Shunt dysfunction occurred (unknown failure) and the valve and bactiseal peritoneal catheter were removed and replaced on (b)(6) 2021.A large amount of blood was found in the explanted valve.It is unknown if the patient experienced any signs and symptoms due to valve failure.
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Manufacturer Narrative
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The bactiseal peritoneal catheter (id 823074) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were noted.The catheter was irrigated no occlusions noted.The catheter was leak tested no leaks noted.No root cause could be determined as the technician could not confirm any problem with the catheter 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 catheter, at the time of investigation the no functional issues were noted with the catheter.
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Event Description
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N/a.
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Search Alerts/Recalls
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