MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSV II 909712; INTERNAL CSF DRAINAGE

Catalog Number	909712
Medical Device Problem Codes	Material Too Soft/Flexible (4007); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
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 that during ventriculoperitoneal (vp) shunt implantation for hydrocephalus procedure, tunneling for the placement of the distal (peritoneal) catheter was performed without complications.After implanting the ventricular catheter into the cerebral ventricle, at the time of connecting the ventricular catheter to the valve, the surgical team observed that the catheter presented a perforation/tear at the connection site.The damaged segment was cut, and the connection attempt was repeated; however, the same issue occurred three consecutive times.Proper coupling was only achieved after extremely delicate handling.In the next step, when positioning the valve in the lateral pocket of the patient¿s head, the device presented bilateral opening, with the onset of cerebrospinal fluid leakage.According to the team¿s report, the material appeared more fragile than usual, resembling a dried or brittle condition, becoming damaged even under careful handling and within standard technique.The issue with the product delayed the procedure by approximately 30 minutes; however, there was no injury to the patient.

• Brand Name: OSV II 909712
• Common Device Name: INTERNAL CSF DRAINAGE
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 25061728
• Report Number: 3013886523-2026-00106
• Device Sequence Number: 13118504
• Product Code: JXG
• UDI-Device Identifier: 10381780034032
• UDI-Public: 10381780034032
• Combination Product (Y/N): N
• PMA/510(K) Number: K971799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 909712
• Device Lot Number: 7567843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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: 32 MO
• Patient Sex: Male