MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS RA SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Catalog Number	828824PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2025
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 valve (id 828824pl) with a defective anti-siphon mechanism.The distal end and ventricular catheter were patent.Valve didn¿t have any obvious plug or clot.Initially, surgeon assumed that the patient needed low pressure but the valve was set to performance level 1.The valve was pumped numerous times and positioned the patient upright.There was suspicion of defective anti-siphon mechanism, therefore, the valve was explanted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The certas valve (id 828824pl) was returned for evaluation.Failure analysis -the position of the cam when valve was received was at setting 1.The valve was visually inspected; no defect noted.The valve passed the test for programming, occlusion, leak, reflux, siphon guard and pressure.Root cause analysis - no root cause could be determined as the technician could not confirm any resistance issue with the valve at the time of investigation.The possible root cause for the issue reported by the customer could have been due to an excessive flow rate (>0.75 ml/min) during the flushing procedure activates the siphon guard and creates the impression that the valve is distally occluded.In reality the flow is being diverted to the high resistance secondary pathway, this will slow the rate at which csf is shunted from the brain.It would probably explain the problem encountered by the customer.

• Brand Name: CRTS RA SG VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA 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: 23037664
• Report Number: 3013886523-2025-00246
• Device Sequence Number: 9181742
• Product Code: JXG
• UDI-Device Identifier: 10381780529491
• UDI-Public: (01)10381780529491
• Combination Product (Y/N): N
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 10/24/2025

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: 828824PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/24/2025
• 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