MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3832

Device Problems Break (1069); Occlusion Within Device (1423); Split (2537); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 01/17/2017

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 the patient with vp-shunt (the initial setting was 170 mm h2o) on (b)(6) 2016.The symptom of a gait disorder was observed on (b)(6), and for this treatment, the valve¿s pressure setting was adjusted.However, for the several months after the treatment, the symptom didn¿t get better.The contrast radiography was performed and as the result, the shunt obstruction was suspected.Also, the protein concentration was 200 to 300 mg and high.The symptom of gait disorder and dementia got worse, and the patient¿s condition went bad.At the end of 2016, a csf tap test was conducted and the patient¿s condition was improved temporally.As the result of the testing, finally the revision surgery was performed on (b)(6) 2017.The valve was removed from the patient (the final setting was 120 mm h2o) and new a valve (82-3832) was implanted (the initial setting was 120 mm h2o).The surgeon visually checked the removed valve and found that the housing was torn and the valve and the sg were split.According to the surgeon, it was not pulled out by applying force at the removal, so it might be possible that it have been already broken when implanting it to the patient at the first place.However, when examining by the contrast radiography, it didn¿t seem to be leaking at the valve part.The patient¿s (b)(6) and the age is (b)(6).The original disease was a brain tumor and the patient was suffering from snph.Currently, the patient¿s condition is being observed.

Manufacturer Narrative

(b)(4).Upon completion of the investigation, it was noted that the images were taken of the ¿as received¿ valve.The position of the cam when valve was received was at 110mmh2o.The valve was visually inspected: and confirms that the silicone housing has been cut/torn needle holes in the needle chamber were also noted.The valve was hydrated for 24 hours.The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test.Due to the damaged silicone housing, it was not possible to flush, leak test, reflux test, siphon guard test or pressure test the valve.The valve was dismantled and was examined under microscope at appropriate magnification: no signs of biological debris were noted on the valve mechanism.The siphon guard was visually inspected and marks in the siphon guard were noted.This is probably due to a sharp or pointed object and the reason for the cut/torn silicone housing.Review of the history device records confirmed the valve product code 82-3832, with lot ctdbm5, conformed to the specifications when released to stock on the 4th may 2015.The root cause to the tear/cut in the silicone housing is probably being due to the user, this however could not be determined.As noted in the ifu silicone has a low tear / cut resistance.Per hhe, 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.The root cause for the problem obstruction suspected by the customer could not be determined no signs of biological debris were noted.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: PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29 case postale; le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6274367
• MDR Text Key: 65639747
• Report Number: 1226348-2017-10062
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992173
• 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: 01/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 82-3832
• Device Lot Number: CTDBM5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2015
• 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: 76 YR