MAUDE Adverse Event Report: SOPHYSA PRESSIO® ICP AND ICT MONITORING KIT, PARECHYMAL TUNNELING; ICP 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	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial: awaiting product return for device analysis.
Event or Problem Description
Icp catheter (referenced pso-ptt) was implanted on the (b)(6) 2025 in correct position.The icp reading and evd reading did not match at all during implantation.Reported inconsistent pso-ptt reading 4, evd reading 14.Def unusual reading on the (b)(6).Removed on (b)(6) 2025.
Event or Problem Description
Icp catheter (referenced pso-ptt) was implanted on the (b)(6) 2025 in correct position.The icp reading and evd reading did not match at all during implantation.Reported inconsistent pso-ptt reading 4, evd reading 14.Def unusual reading on (b)(6).Removed on (b)(6) 2025.

• Brand Name: PRESSIO® ICP AND ICT MONITORING KIT, PARECHYMAL TUNNELING
• Common Device Name: ICP ICT MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy m[ôuet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22606880
• Report Number: 3001587388-2025-00067
• Device Sequence Number: 5443736
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)241125(17)290701
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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 Sex: Unknown