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

Model Number	PSO-PT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Waiting for product return for root cause analysis.
Event or Problem Description
The catheter was implanted with a good waveform but a negative reading for icp of -8.Catheter was replaced and has a good waveform and positive icp readings.
Event or Problem Description
The catheter was implanted with a good waveform but a negative reading for icp of -8.Catheter was replaced and has a good waveform and positive icp readings.
Additional Manufacturer Narrative
Displays 0 mmhg on the monitor in open air.Zero procedure was performed on (b)(6) 2025.Catheter functional and responsive.Monitoring data from the catheter was collected over 1.5 days, with an average pressure close to 5mmhg during the first 6 hours and a peak at 20.Then, negative pressure drop with a few peaks at 10 mmhg over short periods: pressure returns to positive during the last hours of monitoring.The analyzed data confirms the observation made during use: "the catheter was implanted with a good waveform but a negative reading for icp of -8." catheter analysis: - visual: suture threads still present, two squeeze marks visible on the tube between the 20 and 30 mm graduations from the capsule (however kt pso-pt and not pb).Analysis of the sensor integration into the capsule is compliant, with no potential visual defects likely to cause pressure disturbance.- functional: the catheter is tested in warm water (37°c) for several days.The catheter does not exhibit any abnormal behavior, even when manually manipulated, and no disturbed or abnormal values (e.G., negative) are observed.The signal remains perfectly stable at 0-1 mmhg.- traceability: the catheter traceability shows nothing abnormal; the last functional check in production was carried out on (b)(6) 2024 and was compliant.No confirmation of the defect observed during use.

• Brand Name: PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING
• Common Device Name: ICP 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: 23035524
• Report Number: 3001587388-2025-00083
• Device Sequence Number: 9217103
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: (01)03760124130782(11)250219(17)291001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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
• Device Model Number: PSO-PT
• Device Catalogue Number: PSO-PT
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (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