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	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Defective fiber, interference when plugged into mains.Signal artifact/noise.No clinical signs, symptoms or conditions.Device explantation.No clinical situation identified.
Event or Problem Description
Defective fiber, interference when plugged into mains.Signal artifact/noise.No clinical signs, symptoms or conditions.Device explantation.No clinical situation identified.
Additional Manufacturer Narrative
An integration defect is at the origin of the problem.Regarding traceability, everything is compliant.

• 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 moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22019164
• Report Number: 3001587388-2025-25031
• Device Sequence Number: 9484827
• Product Code: GWM
• UDI-Device Identifier: 03760124131758
• UDI-Public: (01)03760124131758(11)250219(17)291201
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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-PBT
• Device Catalogue Number: PSO-PBT
• Device Lot Number: 01/12/2029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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 Age: 46 YR
• Patient Sex: Male