MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM PROG VALVE INLINE SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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.

• Brand Name: HAKIM PROG VALVE INLINE SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8010558
• MDR Text Key: 125185395
• Report Number: 1226348-2018-10761
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K992173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-3842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR