Model Number SPV-SX |
Device Problems
Occlusion Within Device (1423); Use of Device Problem (1670)
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Patient Problem
Hydrocephalus (3272)
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Event Date 03/20/2018 |
Event Type
malfunction
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Event Description
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The physician informs us that the patient has been implanted with an adjustable valve including an anti-siphon in (b)(6) 2017.The implantation of the valve was in the pectoral region.On (b)(6) 2018, hydrocephalus symptoms was observed on the patient, and the physician used the contrast medium to verify the csf drainage : the contrast medium did not flow enough.For additional information, the physician sent the x-ray image and we find that the anti-siphon is in an angular position relative to the valve.This could explain the incident.
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Manufacturer Narrative
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The device was returned to our manufacturing facility for analysis following our quality control procedure.Visual examination: no particles or deposits were found inside the valve and no marks was apparent on the body.The valve is clean.There is only 3,5 mm left of catheter stuck on the outlet connector.The other piece and the siphonx have not been returned by the user.Functional controls: the ability of the valve to perform was tested.In the state of return, the valve is possible to flush with air.It confirms that there is no obstruction.The ability to turn the rotor was tested upon return and after cleaning.The rotation is possible both before and after cleaning.The valve is compliant.The valve is 100% controlled (pressure/flow characteristics, visual controls, etc.) during the manufacturing.A review of the fabrication record showed no anomalies in conclusion, the valve meets its specifications however the catheter was broken due to a too high tensile on it.The root cause could be determined mishandling.
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Event Description
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The physician informs us that the patient has been implanted with an adjustable valve including an anti-siphon in (b)(6) 2017.The implantation of the valve was in the pectoral region.On (b)(6) 2018, hydrocephalus symptoms was observed on the patient, and the physician used the constrast medium to verify the csf drainage: the contrast medium did not flow enough.The valve had been explanted and replaced.For additional information, the physician sent the x-ray image and we find that the anti-siphon is in an angular position relative to the valve.This could explain the incident.
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Search Alerts/Recalls
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