MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ BACTISEAL & SG

Catalog Number	828807PL
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A physician reported a certas valve (id: 828804pl) was implanted on (b)(6) 2023.The patient came back for a shunt revision due to the valve not flowing properly, patient symptoms did not improve, therefore, the valve was removed and replaced on (b)(6) 2023.It was tested with a monometer which confirmed it was not draining properly.The valve was set at setting 3 but did not drain properly based on that setting.The patient symptoms improved after the valve was changed and doing better now.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:  d9, g3, g6, h2, h3, h6, h10.Unique device identification (udi): (b)(4).The certas valve (id 828806) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 2.The valve was visually inspected; no defects noted.The valve passed the tests for programming, occlusion, leaks, reflux and siphon guard.The valve failed the test for pressure.The valve was dismantled and was examined under microscope at appropriate magnification.Biological debris was noted on the ruby ball and on flat spring of cam/ball arm assembly.Root cause - the root cause for the issue reported by the customer, is due to biological debris and protein build found on the ruby ball and on flat spring of cam/ball arm assembly.
Additional Manufacturer Narrative
Device history record (dhr) update¿ the product code 82-8807pl with lot 6979000, conformed to the specifications when released to stock.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Common Device Name: CERTAS PLUS W/ BACTISEAL & SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17209559
• Report Number: 3013886523-2023-00189
• Device Sequence Number: 6798762
• Product Code: JXG
• UDI-Device Identifier: 10381780521280
• UDI-Public: (01)10381780521280(17)240430(10)6979000
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 828807PL
• Device Lot Number: 6979000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 03/12/2024
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/28/2023; 03/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown