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 Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 03/22/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Valve did not work anymore and therefore was replaced.

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 110 mm h2o.The valve was hydrated.The valve was visually inspected; it was noted that the needle guard was missing, and the needle chamber silicone was cut/torn in 3 places.The valve was tested for programming with programmer 82-3126 with serial number (b)(4) and programmer 82-3190 with serial number (b)(4), the valve failed the test, the cam mechanism did not move during the programming process.The valve could not be flushed, leak tested, or siphon guard tested due to the missing needle guard and the damaged silicone housing.The valve was dried.The valve could not be pressure tested, due to the missing needle guard and the damaged silicone housing.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, on the cam mechanism, in the cam mechanism pillar, and on the base plate.The cam magnets were also controlled.The magnets passed.The lot history record was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, they were released to stock on the 26th june 2005.The root cause of the programming problem is due to the biological debris found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, on the cam mechanism, on the cam mechanism pillar, and on the base plate.The root cause for the damaged silicone housing in the needle chamber is probably due to user error as noted in the ifu silicone has a low tear/cut resistance, this however could not be determined.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 missing needle chamber base could be in connection with the damaged silicone housing, this however could not be determined.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; le locle CH 24 00; SZ CH 2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6489627
• MDR Text Key: 72732793
• Report Number: 1226348-2017-10255
• 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: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2010
• Device Catalogue Number: 82-3832
• Device Lot Number: 1315351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2005
• 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