CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS PLUS INLINE WITH SIPHONGUARD VALVE SEPARABLE CATHS; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
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Catalog Number 82-8805 |
Device Problem
Programming Issue (3014)
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Patient Problem
Hematoma (1884)
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Event Date 02/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) it has been reported that the device will be returned for evaluation.Upon completion of the investigation, a supplemental mdr will be submitted.
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Event Description
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It was reported that during implantation, the certas valve was unable to be programmed.The patient was (b)(6) male.The valve insertion was done via lp-shunt, on (b)(6) 2018.However, during the implant procedure, a subdural hematoma was developed.The ventricular catheter was inserted and the valve attached.The physician attempted to adjust the pressure setting to 8 but it could not be changed.Per the affiliate, the physician thinks that the pressure setting issue of the valve is related to subdural hematoma.The valve was removed and the catheter was ligated with a suture to prevent csf drainage after left in place.The patient will still require a valve placement, but timing is unknown.After the valve was removed, the physician could adjust the setting.Per the physician, it seems that the valve was placed deeper than 1 cm.No further information was provided by hospital.
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Manufacturer Narrative
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The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
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Manufacturer Narrative
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The previously reported date of device return was incorrect.This report has been updated to reflect the corrected information.
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Manufacturer Narrative
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The valve was returned for evaluation.The position of the cam when valve was received was at setting 5.The valve was visually inspected; some fixed biological debris was noted on the wall of the needle chamber.The valve was tested for programming and passed the test.The valve was flushed; no occlusion was found.The valve was leak tested; no leaks noted.The valve was reflux tested and passed.The siphon guard was tested and passed.The siphon guard was removed.The valve was then pressure tested, with no issues found.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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