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

Catalog Number	828804PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2024
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 facility reported a certas plus valve was implanted on (b)(6) 2024 4 due to hydrocephalus.The patient returned and a new valve was implanted.Surgeon suspects the valve was defective.No additional information available.
Additional Manufacturer Narrative
Updated fields: b3, d4, d9, e1, g3, g6, h2, h3, h4, h6, h10, h11.The certas valve (id 828804pl) was returned for evaluation.Device history record (dhr) ¿ product code 82-8804pl with lot 7354876, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 1.The valve was visually inspected; a needle hole in the needle chamber was noted.The valve passed the test for programming, occlusion.Reflux, and siphon guard.The valve was leak tested; only leaked from the needle hole in the needle chamber.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 noted the ruby ball.Root cause analysis - the root cause for the issue reported by the customer is due to biological debris and protein build up found on the ruby ball.This debris is stopping the ruby ball from being seated correctly.Additional information received (medwatch report (b)(4)): date of event: (b)(6) 2024.Explantation date: (b)(6) 2024.Initial reporter (b)(6).Phone (b)(6).Email (b)(6).Contact name (b)(6).Phone (b)(6).Report sent to manufacturer: june 2024.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Common Device Name: CERTAS PLUS W/ 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 08540 ; 6099362319
• MDR Report Key: 19590014
• Report Number: 3013886523-2024-00178
• Device Sequence Number: 14329046
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: (01)10381780521174(17)281231(10)7354876
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 828804PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown