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	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter was implanted the 4th of september.External ventricular drain and intracranial pressure were correlated until the 9th of september.At 10pm the reading of the intracranial pressure became high, increased up to 57.The catheter was explanted.The catheter was initally checked and was in position in the brain.
Event or Problem Description
The catheter was implanted the (b)(6).External ventricular drain and intracranial pressure were correlated until the (b)(6).At 10pm the reading of the intracranial pressure became high, increased up to 57.The catheter was explanted on (b)(6) 2025.The catheter was initially checked and was in position in the brain.
Additional Manufacturer Narrative
Zero procedure was performed on (b)(6) 2025.Monitoring data from the catheter was collected over 6 days.The mean pressure recorded was very low (around 0 mmhg), with high-pressure spikes that became more frequent on the last day.No pressure data of 57 mmhg was recorded, as reported by the healthcare professional.Catheter analysis: visual: the catheter was compliant despite several strong bends.Functional: it met manufacturing specifications, with no abnormal high pressure observed during several days of testing.Traceability: no issue was found that could support the incident.The defect could not be reproduced.

• 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 moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 23109258
• Report Number: 3001587388-2025-00086
• Device Sequence Number: 15966068
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)250625(17)300201
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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-PTT
• Device Catalogue Number: PSO-PTT
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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