MAUDE Adverse Event Report: SOPHYSA PRESSIO® INTRACRANIAL PRESSURE MONITORING KIT, PARENCHYMAL TUNNELLING; ICP MONITORING CATHETER

Model Number	PSO-PT
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When monitoring the pressure, an error message indicating an "internal memory problem" appeared on the monitor.Changing the monitor did not resolve the issue.Replacing the pressure sensor with the same reference restored normal operation.Estimated time lost: approximately 15 minutes.The incident had no patient consequence.
Additional Manufacturer Narrative
This incident has no consequences for the patient, and therefore did not result in death, nor a serious and immediate deterioration of the patient's health.The incident does not pose a threat to public health.Traceability did not show any anomalies during the last check before packaging.Investigations does show a memory defect.The memory defect likely appears once the true zero of the catheter has been establihed.
Event or Problem Description
When monitoring the pressure, an error message indicating an "internal memory problem" appeared on the monitor.Changing the monitor did not resolve the issue.Replacing the pressure sensor with the same reference restored normal operation.Estimated time lost: approximately 15 minutes.The incident had no patient consequence.

• Brand Name: PRESSIO® INTRACRANIAL PRESSURE MONITORING KIT, PARENCHYMAL TUNNELLING
• Common Device Name: ICP MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22850368
• Report Number: 3001587388-2025-00079
• Device Sequence Number: 11852669
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: (01)03760124130782(11)241224(17)290901
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: PSO-PT
• Device Catalogue Number: PSO-PT
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2024
• 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