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	Unexpected Shutdown (4019)
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
Patient monitored in icu for 10 hours.The pressio2 monitor battery depleted as it was not plugged in.When plugged in, catheter did not read.Monitor flashed, ticked over (made a noise).Tried a new monitor and cables with the catheter.Monitor flashed, would not accept catheter.Catheter was noted as placed correctly via mri.Explanted.
Event or Problem Description
Patient monitored in icu for 10 hours.The pressio2 monitor battery depleted as it was not plugged in.When plugged in, catheter did not read.Monitor flashed, ticked over (made a noise).Tried a new monitor and cables with the catheter.Monitor flashed, would not accept catheter.Catheter was noted as placed correctly via mri.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: 22643138
• Report Number: 3001587388-2025-00068
• Device Sequence Number: 18333625
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)250204(17)291201
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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