MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELING; ICP AND ICT MONITORING CATHETER

Model Number	24D16661
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Discrepancies in icp catheter reading.Large fluctuations.Similar issues with the new catheter inserted after.Time of implantation: (b)(6) 2025.Position checked: (b)(6) 2025.Time of explanation: (b)(6) 2025.
Additional Manufacturer Narrative
Visual inspection : general aspect compliant, blood deposits on the catheter.Correct position of microwire.Functional test : monitoring during 3 days.Slight interference appears on the second day and seems to increase slightly on the third; before the connection is lost, the signal appears to intensify slightly.After several days of laboratory testing, no noise phenomen is observed.Traceability : last functional testing compliant on 01/13/2025.
Event or Problem Description
Discrepancies in icp catheter reading.Large fluctuations.Similar issues with the new catheter inserted after.Patient returned to operating room on (b)(6) 2025 with high icp for an external ventricular drain.Time of implantation: (b)(6) 2025.Time of explanation: (b)(6) 2025.

• Brand Name: PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELING
• Common Device Name: ICP AND ICT MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy môquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 23742816
• Report Number: 3001587388-2025-00132
• Device Sequence Number: 10150644
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)250625(17)300401
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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 Model Number: 24D16661
• Device Catalogue Number: PSO-PTT
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown