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

Model Number	82-8804PL
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the sales rep, a certas plus valve with siphonguard was occluded and had no flow during the implantation procedure.A non-codman valve was used to successfully complete the procedure.There were no reports of delay or patient harm.
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
(b)(4).The device was returned for evaluation.The position of the cam when valve was received was at setting 1.The valve was visually inspected; biological debris was noted in the valve mechanism.The valve was tested for programming and failed the test; the cam mechanism did not move.The valve was flushed; the valve was blocked.The siphon guard was removed from the valve and tested; the siphon guard passed the test.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the ruby ball, on the flat spring of cam / ball arm assembly, on the titanium axle, on the rotating construct, on the base and the top of the valve casing.A review of manufacturing records found the device conformed to specification when released to stock.The root cause for the problems found during investigation are likely due to the biological debris found on the ruby ball, on the flat spring of cam / ball arm assembly, on the titanium axle, on the rotating construct, on the base and the top of the valve casing.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle, CH240 0; SZ CH2400
• MDR Report Key: 7709973
• Report Number: 1226348-2018-10501
• Device Sequence Number: 14146178
• Product Code: JXG
• UDI-Device Identifier: 10886704079040
• UDI-Public: (01)10886704079040
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 82-8804PL
• Device Catalogue Number: 82-8804PL
• Device Lot Number: 187031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 07/26/2018; 10/08/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/16/2018; 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1