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

Model Number	PSO-PT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Icp catheter inserted on (b)(6) 2025, with inaccurate readings {negative readings} and poor waveforms for 24 hours so it was replaced on (b)(6) 2025 and readings and waveform much better.
Event or Problem Description
Icp catheter inserted on (b)(6) 2025, with inaccurate readings (negative readings) and poor waveforms for 24 hours so, it was replaced on (b)(6) 2025 and readings and waveform much better.

• 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: 22870948
• Report Number: 3001587388-2025-00080
• Device Sequence Number: 21112934
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: (01)03760124130782
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062584
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 02/05/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown