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

Catalog Number	828814PL
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2025
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 physician reported a certas plus small valve with siphonguard (id 828814pl) was used during procedure and the doctor observed that cerebrospinal fluid (csf) was not draining through the distal tip opening of the valve, located below the siphonguard.Additionally, it appeared that the valve was leaking csf at the base of the siphonguard.The event happened during procedure (before implantation site closure) and a slight delay was reported.The procedure was completed with a replacement product available.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h11.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; needle hole was noted in the needle chamber.The valve was hydrated and irrigated, valve popped.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The valve was leak tested and failed.Leak was observed at the base of the siphon guard.The siphon guard was observed under microscope, cut mark and tear were observed.Root cause analysis: the possible root cause for the leakage issue, could be due to improper handling of the device in view of the cut mark at the connection between the peritoneal connector and the siphon guard.The root cause for the "cut mark" is due to a sharp or pointed object coming into contact with the valve in view of cut mark at the connection between the ventricular connector and the needle chamber.As noted in the surgical procedure precautions section in ifu, silicone has a low cut/tear resistance.The possible root cause for the obstruction issue could be due to human misuse because the doctor does not perform irrigation before implantation but according to ifu "irrigation is required before implantation to help ensure proper performance".
Event or Problem Description
N/a.

• Brand Name: CRTS SM IL 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: 22809213
• Report Number: 3013886523-2025-00208
• Device Sequence Number: 8951454
• Product Code: JXG
• UDI-Device Identifier: 10381780529378
• UDI-Public: 10381780529378
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 828814PL
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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
• Patient Age: 6 YR
• Patient Sex: Female