MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SML SGA VLV; INTERNAL CSF DRAINAGE

Catalog Number	828814PL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a certas valve (id (b)(6)) was implanted on (b)(6) and then removed and replaced due to an increase in intracranial pressure (icp).As per reporter, the patient experienced signs and symptoms of increased icp, however, details were not provided.
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.
Additional Manufacturer Narrative
The certas valve (id (b)(6)) was returned for evaluation: failure analysis - the position of the cam when valve was received was at setting 8.The valve was visually inspected, no defect noted.The valve was irrigated and hydrated.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 problem at the time of investigation.The possible root cause for the issue reported by the customer, could be due to biological debris occluding the catheter or a kink in the catheter.
Event or Problem Description
N/a.

• Brand Name: CRTS SML SGA VLV
• 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: 24469894
• Report Number: 3013886523-2026-00027
• Device Sequence Number: 18711571
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 828814PL
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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