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

Model Number	PSO-PTT
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial: awaiting product return for device analysis.
Event or Problem Description
Icp readings for up to 10 hours.Patient went to ct.When connecting the icp catheter back to the monitor no reading could be obtained.Noted connect catheter.A second pressio2 and cables were used.Still unable to get a reading.Icp catheter explanted.
Event or Problem Description
Icp readings for up to 10 hours.Patient went to ct.When connecting the icp catheter back to the monitor no reading could be obtained.Noted connect catheter.A second pressio2 and cables were used.Still unable to get a reading.Icp catheter explanted.

• Brand Name: PRESSIO® ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELING
• Common Device Name: ICP ICT 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: 22662991
• Report Number: 3001587388-2025-00070
• Device Sequence Number: 17069328
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)250408(17)300101
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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-PTT
• Device Catalogue Number: PSO-PTT
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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