MAUDE Adverse Event Report: SOPHYSA PRESSIO® ICP MONITORING KIT, VENTRICULAR TUNNELING; ICP MONITORING CATHETER

Model Number	PSO-VT
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial: pending more informations to perform a batch review and awaiting the product return for device analysis.
Event or Problem Description
A pso-vt was indicated to monitor icp in a case of traumatic brain injury.During follow-up, an error e001 has occured on the monitor pso-3000.There is no clinical signs or symptoms.
Additional Manufacturer Narrative
Initial: pending more informations to perform a batch review and awaiting the product return for device analysis.Final: user error.
Event or Problem Description
A pso-vt was indicated to monitor icp in a case of traumatic brain injury.During follow-up, an error e001 has occured on the monitor pso-3000.There is no clinical signs or symptoms.

• Brand Name: PRESSIO® ICP MONITORING KIT, VENTRICULAR TUNNELING
• Common Device Name: ICP MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy môquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22382109
• Report Number: 3001587388-2025-00057
• Device Sequence Number: 15811723
• Product Code: GWM
• UDI-Device Identifier: 03760124131482
• UDI-Public: (01)03760124131482(11)241120(17)290801
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K062584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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 Model Number: PSO-VT
• Device Catalogue Number: PSO-VT
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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: Male