MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON 828804PL; INTERNAL CSF DRAINAGE

Catalog Number	828804PL
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	02/16/2026
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: "on (b)(6), the patient had an external ventricular drain (evd) removed and a certas valve implanted, draining from the other ventricle.Over the weekend, it was discovered that the patient was leaking cerebrospinal fluid (csf) from the evd incision.They concluded that the shunt was not draining properly.On (b)(6), a shunt revision was conducted.The shunt was tested prior to explant.Csf was not flowing from the distal catheter or the distal end of the valve.When the shunt was disconnected from the ventricular catheter, csf flowed freely.A second shunt (id 828814pl) was connected to the ventricular catheter.A manometer was connected to the distal end of the shunt.This time, csf seemed to flow much faster through the valve than expected and the valve was not regulating flow.The issue was detected before implantation site closure and led to five-minute delay.A third shunt was connected (id 828810pl) to the ventricular catheter.This shunt also demonstrated some sort of issue with csf flow.They cannot remember exactly what the issue was.The issue with the third valve was detected before implantation site closure and led to five-minutes delay.A fourth shunt was connected and it performed as expected and was implanted.".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The certas valve ((b)(6) was returned for evaluation.Failure analysis - the position of the cam when the valve was received was at setting 3.The valve was visually inspected; no defect was noted.The valve passed the test for programming, occlusion, leak, reflux, siphon guard and pressure.The valve functions.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve accumulation of biological matter within the valve can cause difficulties adjusting the valve setting with the tool kit and impair the anti-reflux function.Complications of implanted shunt systems include mechanical failure, shunt pathway obstruction, infection, foreign body (allergic) reaction to implants, and csf leakage along the implanted shunt pathway.Clinical signs such as headache, irritability, vomiting, drowsiness, or mental deterioration might be signs of a nonfunctioning shunt.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON 828804PL
• Common Device Name: INTERNAL CSF DRAINAGE
• 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: 24616383
• Report Number: 3013886523-2026-00052
• Device Sequence Number: 9639998
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: 10381780521174
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 828804PL
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/01/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown