MAUDE Adverse Event Report: RAYNHAM HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number XXX-HAKIM PROGRAMMABLE VALVE

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Headache (1880); Nausea (1970); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

2 of 2 reports: other mfg report number: 3013886523-2021-00026.Korean j neurotrauma (2016) published."shunt overdrainage caused by displacement of the pressure control cam after pressure adjustment".Purpose: the purpose of this report is to provide a working knowledge of the valve structure and to enhance the ability to interpret the valve setting on an x-ray for diagnosis of valve malfunction.Case report: "a (b)(6) year-old female underwent a ventriculoperitoneal shunt operation with a codman-hakim programmable valve for hydrocephalus after subarachnoid hemorrhage.Her symptoms of hydrocephalus had been improving since the operation, but she complained of slowly aggravating headache and nausea for recent years.Her brain computed tomography (ct) showed a slit-ventricle, and the skull x-ray revealed the valve pressure at 10 mmh2o.The valve pressure was adjusted to 12 mmh2o at the outpatient department.A few days later, she presented with even worsening headache and nausea.She had no history of direct trauma on the valve or an exposure to magnetic fields.The skull x-ray showed that the pressure control cam was detached from the base plate and displaced distally.She underwent revision of the shunt system to exchange the valve.A microscopic inspection of the valve revealed the detachment of the cam from the base plate leaving the x-shaped slit empty.The displacement of the cam relaxed the flat spring pressure on the valve ball, and it led to over drainage of the csf.After the shunt revision, her symptoms dramatically resolved and her brain ct showed recovery from the slit-ventricle." adverse events: headache, nausea, revision surgery.Conclusion: although the codman-hakim programmable valve is generally very useful in terms of noninvasive pressure adjustment and fine tuning of valve pressure, a rare complication such as displacement of the pressure control cam may occur.An accurate knowledge on the valve structure as well as an ability to interpret the valve status on an x-ray are essential to confirm maintenance of this elaborate device and recognize the presence of valve malfunction.

Manufacturer Narrative

The hakim valve was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11174402
• MDR Text Key: 230710678
• Report Number: 3013886523-2021-00027
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-HAKIM PROGRAMMABLE VALVE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR