MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8804PL

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Certas valve was not working.Dr.Was not sure why.Original date of implant was (b)(6) 2016 and patient was doing well.She began to crash and they revised her on (b)(6) 2016.

Manufacturer Narrative

Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

Device evaluation: date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes, additional mfr narrative.Upon completion of the investigation it was noted that the position of the cam when valve was received was at setting 3.The valve was visually inspected: a needle hole in the needle chamber was noted.The valve was hydrated for 24 hours.The valve was tested for programming.The valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, leaked from the needle hole in the needle chamber.The valve was reflux tested, the valve passed the test.The siphon guard was tested.The valve passed the test.The valve was dried.The valve was then pressure tested, the valve failed the test.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the ruby ball, this debris was probably stopping the ruby ball from sitting correctly on the seat of the ruby ball.Review of the history device records confirmed the valve product code 82-8805pl, with lot ctmb87, conformed to the specifications when released to stock in 3rd november 2015.The root cause for the pressure problem found during investigation was due to biological debris on the ruby ball.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: CERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY
• 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: 6138720
• MDR Text Key: 61234092
• Report Number: 1226348-2016-10824
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-8804PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR