A physician reported underdrainage of a shunt valve.A certas valve was implanted in a patient via ventricular peritoneal shunt on (b)(6) 2021.During the surgical procedure, the valve was pumped to check for patency, but the flow rate was reportedly unstable.The physician used another product in which they could do the pumping without problems.No information of surgical delay was available from the hospital.
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The valve was returned for evaluation.Review of the history device records for the product code 82-8806 with lot number 4739009, conformed to the specifications when released to stock failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; no defects were noted.The valve was hydrated.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 after steam sterilization the ruby ball sticks to the ruby seat¿ and potential effects of failure include ¿'excessive pressure required to flush the valve pre-procedure ("valve popping").
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