CODMAN & SHURTLEFF, INC. HAKIM PROG VALVE INLINE SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
|
Back to Search Results |
|
Catalog Number 82-3842 |
Device Problem
Obstruction of Flow (2423)
|
Patient Problems
Failure of Implant (1924); Neurological Deficit/Dysfunction (1982)
|
Event Date 10/04/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
|
|
Event Description
|
It was reported by the affiliate that the hakim valve and catheter contained a blockage.A revision took place and during the revision, the shunt flow was confirmed.The valve was implanted in a v-p application for treatment of normal pressure hydrocephalus (nph).Initial setting were unknown.The patient had been under monitoring and no defect was confirmed.Then difficulty with walking and cognitive dysfunction were confirmed on the patient and she visited the hospital.Ventricular enlargement was diagnosed by imagining check-up and the valve setting was changed from 160 mmh2o to 80mmh2o.However ventricular contraction was not confirmed.By the angiography, the contrast media flow on the ventricle side, however, the contrast media flow from the shunt to the distal was not confirmed.The surgeon suspected that the distal of the catheter was blocked, therefore, revision of the abdominal catheter was performed.It was confirmed that there was some white material in the explanted catheter that could have blocked the flow.Also, the drops from the shunt system was confirmed.There was no contamination of blood or debris in the cerebrospinal fluid confirmed.No change of the patient confirmed.The ultra x ray of the shunt was done due to suspicious catheter blockage.The setting of the shunt was 80 mmh2o at revision.The patient is under monitoring now, but ventricular contraction is not confirmed yet.The surgeon is planning to lower the setting even more.There was no surgical delay and there was no adverse consequence to the patient.No further information was provided by hospital.The products will be returned to your site.
|
|
Manufacturer Narrative
|
Two pieces of catheter were returned for evaluation.Tone is 9cm long, and the other is 3cm long.The 2 pieces of catheter were irrigated, no occlusions noted or leaks were noted.A review of the history device records was not possible as the lot number was unknown.No root cause could be determined, as no occlusion was 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.
|
|
Search Alerts/Recalls
|
|
|