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

Model Number	PSO-PT
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An intracranial pressure sensor (reference pso-pt / serial number: (b)(6) was implanted on (b)(6) 2025.When this sensor is connected to the module, the latter malfunctions: it turns off and on again even though the battery is fully charged and the module is connected to the mains.This prevents the sensor from being calibrated, rendering it unusable.Another monitor (pso-4000) is then used: failure of the monitor, which goes into default mode.
Event or Problem Description
When the sensor (reference pso-pt/serial number (b)(6) is connected to the module, the latter malfunctions: it turns off and on again even though the battery is fully charged and the module is connected to the mains.This prevents the sensor from being calibrated, rendering it unusable.Another monitor (pso-4000) is then used: failure of the monitor, wich goes into default mode.This incident occured before implantation.
Additional Manufacturer Narrative
The catheter's traceability shows nothing abnormal, with the last functional test in production carried out on (b)(6) 2024 and found to be compliant.Investigations on the device does show a memory defect.The visual analysis of the dongle board shows the presence of the suspected faulty stm eeprom component.The capa 2025-04 opened on the subject of monitor reboots, and still ongoing, addresses the various investigations carried out on the matter.

• 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: 23435525
• Report Number: 3001587388-2025-00111
• Device Sequence Number: 20965818
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: (01)03760124130782(11)250609(17)300201
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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-PT
• Device Catalogue Number: PSO-PT
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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
• 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