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

Model Number	PSO-PT
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Error e001 observed on the monitor.Then, the catheter has been explanted.
Event or Problem Description
Error e001 observed on the monitor.Then, the catheter has been explanted.
Additional Manufacturer Narrative
This report is being resubmitted because the previous report sent on 04/01/2025 (increment 00003) was not accepted.The analysis shows that error e001 confirmed to the monitor, probably due to breakage of the micro-cable in the tube.Analysis of the data shows that the catheter functioned without problem for approximately 5 days (from 08/01 to 13/01/25) with consistent and stable pressure values (average of 3 mmhg).Abnormal excessive traction during use definitively damaged the catheter, causing the e001 error noted during use.No other observations.Final report of the case (b)(4).

• 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; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 21228876
• Report Number: 3001587388-2025-25012
• Device Sequence Number: 15539051
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: (01)03760124130782(11)231016(17)280901
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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