MAUDE Adverse Event Report: SOPHYSA PRESSIO® ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELLING; ICP AND 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)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sensor was implanted and working well.Nurse has disconnected sensor from monitor to do something with patient.They has tried to reconnected the sensor to the monitor, to which the monitor then was making sound and turning on and turning off.They tried 4 other monitors and the same issue happened with all 4 monitors.All 4 monitors kept turning off and on when connected to the sensor.2 monitors would show a wave form and pressure for 10 seconds then shut off again.

• Brand Name: PRESSIO® ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELLING
• Common Device Name: ICP AND ICT 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: 23290920
• Report Number: 3001587388-2025-00092
• Device Sequence Number: 15947631
• 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 Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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-PTT
• Device Catalogue Number: PSO-PTT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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