MAUDE Adverse Event Report: Sophysa Pressio ICP monitoring kit, parenchymal tunneling; 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)
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter worked directly after the implantation in or but after a short while showed wrong numbers (low and high) and surgeon choosed to exchange it for a new one which then worked.

• Brand Name: Pressio ICP monitoring kit, parenchymal 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; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 25252453
• Report Number: 3001587388-2026-00038
• Device Sequence Number: 14806966
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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?: Yes
• Date Returned to Manufacturer: 05/21/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2026
• 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