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

Catalog Number NS-9008

Device Problems Break (1069); Leak/Splash (1354); Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

The reported valve was implanted to a patient on (b)(6) 2012 via lp-shunt with ns9008 (setting is 100 mm h2o) due to idiopathic normal pressure hydrocephalus.After that, the patient visited hospital for the first time in 4 years because the patient felt difficulty with walking on (b)(6) 2016.The surgeon checked the pressure setting under x-ray, then, the surgeon noticed that the pressure setting was changed to 120 mm h2o.The patient took mri couple of years ago at different hospital.Then, the surgeon lowered the pressure from 120 mm h2o to 80 mm h2o.However, the patient¿s condition did not get better, so the surgeon attempt to check the shunt flow under x-ray on (b)(6) 2017.The surgeon found the leakage at valve, and suspected the valve was broken during the implantation.The revision surgery was performed on (b)(6) 2017 with competitive valve (medtronic strata with unknown pressure setting).After the surgery, the surgeon checked the condition of the valve in question, and it was found that the connection between the valve and the siphon guard was broken.The patient said that he did not shock the vicinity of the valve.The patient is (b)(6), male, and (b)(6).His condition is now getting better, so he was discharged on (b)(6) 2017.The surgeon commented that he does not know the detail during the implanting surgery, but he suspected that there might be an impact to the valve during the implantation.No further information was provided by hospital.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the images were taken of the valve ¿as received¿.The valve was visually inspected; it was noted that the silicone housing was torn as well as 2 small marks in the hard plastic of the siphon guard.The position of the cam when valve was received was 90 mmh2o.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve could not be leak tested, due to the damaged silicone housing.The catheter was irrigated, no occlusions were noted.The valve could not be reflux tested due to the damaged silicone housing.The siphon guard could not be tested due to the damaged silicone housing.The valve was dried.The siphon guard was removed.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code ns9008, with lot cmmb5l, conformed to the specifications when released to stock on the 5th november 2011.The root cause for the tear/cut in the silicone housing is probably due to the user, this however could not be determined.As noted in the ifu silicone has a low tear / cut resistance.Per hhe (health hazard evaluation) it has been concluded that silicone housing tears are not design related, in order for the housing tear to occur the user has to compromise the silicone through a nick or tear in order for the event to occur.Validation testing demonstrates a robust design.Testing has shown that if the silicone housing has been compromised, a housing tear is likely to occur.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: HAKIM VALVE
• 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
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6551891
• MDR Text Key: 74642026
• Report Number: 1226348-2017-10312
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: NS-9008
• Device Lot Number: CMMB5L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR