MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE VALVE WIHOUT PRECHAMBER; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3101

Device Problem Restricted Flow rate (1248)

Patient Problem Pain (1994)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that a hakim valve was blocked after implantation and was revised.The valve was implanted to the patient; however, initial setting are unk.It was reported that the patient had a headache so the revision surgery was performed.The ventricular catheter was short, so the catheter's revision surgery was performed on (b)(6) 2018 (the valve was not revised).However, some damage of the valve was confirmed when the surgeon tried to change the pressure setting after the surgery, so the valve was revised.The sales force scheduled an interview the surgeon and will collect more detail.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.The patient¿s (b)(6) female.The surgeon commented that probably the valve got damaged when its pressure setting was change as its cam was came off.

Manufacturer Narrative

The device was returned for evaluation.The valve was visually inspected it was noted that the stator and x ray dot were dislodged as well as a crack and a bump mark were noted in the valve casing.Due to the condition of the valve, the cam position/pressure could not be determined.The valve was dismantled and was examined under microscope at appropriate magnification: a crack and a bump mark was noted in the valve casing.This is likely due to the valve receiving a hard knock.Corrosion was also noted on the stator and the x ray dot.The cam magnets were controlled per process and passed testing.A review of manufacturing records found the device conformed to specification when released to stock.The root causes for the dislodged stator and x ray dot could be partly due to the valve receiving a hard knock.The root cause for the crack and bump mark in the valve casing is due to the valve receiving a hard knock.The root cause of the corrosion could not be clearly determined.Stator dislodgement of chpv has been previously investigated.The investigation concluded that several factors may contribute to the stator dislodgement.Trauma to the valve, whether it occurs while implanted or at explant, was the root cause of stator dislodgement.Galvanic corrosion could not be established as a direct root cause for those valves investigated, however it was found to be a contributing factor when trauma to the valve was found.Corrosion, when it arises, only arises after long term exposure to csf.This issue will continue to be monitored through monthly complaint trending and the post market surveillance process.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMABLE VALVE WIHOUT PRECHAMBER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 7785106
• MDR Text Key: 117167933
• Report Number: 1226348-2018-10580
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• 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: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2010
• Device Catalogue Number: 82-3101
• Device Lot Number: CFLB0W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR