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

Model Number	PSO-PBT
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter was placed as usual with no immediate issues.After disconnecting the catheter from the extension cable and attempting to reconnect it, the pressio began cycling on and off repeatedly, rendering it unusable.Connecting a spare new catheter resolved the issue.
Additional Manufacturer Narrative
After connecting the catheter to a monitor for more than 80s the monitore shutdown.This occur also when a another monitor is used.A traceability analysis has been conducted on the manufacturing file of the device.A traceability analysis has been conducted and it did not reveal any clue to support the defect (last functional check in production on 01/16/2024).The visual analysis of the dongle board shows the presence of the faulty stm eeprom component.The capa 2025-04 opened on the subject of monitor reboots is still ongoing, and it addresses the various investigations carried out on the subject.
Event or Problem Description
The catheter was placed as usual with no immediate issues.After disconnecting the catheter from the extension cable and attempting to reconnect it, the pressio began cycling on and off repeatedly, rendering it unusable.Connecting a spare new catheter resolved the issue.

• Brand Name: PRESSIO® ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
• 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: 23071773
• Report Number: 3001587388-2025-00085
• Device Sequence Number: 4645603
• Product Code: GWM
• UDI-Device Identifier: 03760124131758
• UDI-Public: (01)03760124131758(11)240312(17)290101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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-PBT
• Device Catalogue Number: PSO-PBT
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 03/20/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FSCA 2025-04
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown