A facility reported a codman hakim precision fixed pressure valve in-line valve was implanted in a patient on (b)(6) 2021.The facility reported fluid was tracking around the valve and the decision was made to tap the shunt.The site was prepped and draped in sterile fashion.A 23-gauge butterfly needle was inserted into the reservoir.There was an immediate return of clear cerebral spinal fluid, dripping briskly.The opening pressure was 6-7cm.With proximal portion occluded there was sluggish to no distal runoff.Subsequently, 25 milliliters of cerebral spinal fluid were withdrawn, after fontanelle was soft, slightly concave.The provider then attempted to flush distally.The patient was re-prepped and draped.A butterfly needle was inserted into the reservoir.There was again immediate return of clear cerebral spinal fluid, with an opening pressure of 4-5cm.With the occluded proximal catheter, 10 milliliters were flushed through the distal portion.With proximal portion occluded, no distal runoff, fluid column rose and bubbled over the end of the tubing.Proximal portion occluded; another 20 milliliters flushed distally.Again, noted to have brisk drainage when nothing occluded, when proximal portion occluded, fluid stopped draining and fluid column rose-up the tubing to the top.Findings were consistent with distal malfunction.The patient was taken to the operating room on (b)(6) 2021 for a shunt revision.
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Certas valve was not returned for evaluation after three good faith attempts (gfes) were made; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint could be due to biological debris and protein build up interfering with the device.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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