MAUDE Adverse Event Report: SOPHYSA PRESSIO® ICP AND ICT MONITORING KIT, PARENCHYMAL 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	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial: pending more informations to perform a batch review and awaiting the product return for analysis.
Event or Problem Description
Icp catheter implanted (b)(6).Negative reading of 1-2 initially, good waveform.The following morning icp had gradually decreased -10 -12 readings & waveform dampened.Mri noted correct position.Connecting cables, no change in reading.Phillips monitor replicated the p2 reading.Patient taken back to ot.Catheter explanted and a new one implanted.
Additional Manufacturer Narrative
Initial: pending more informations to perform a batch review and awaiting the product return for analysis.Final: during device investigation, the values displayed were consistent and stable: the catheter is consistent with the specifications.
Event or Problem Description
Icp catheter implanted july 1st.Negative reading of 1-2 initially, good waveform.The following morning icp had gradually decreased -10 -12 readings & waveform dampened.Mri noted correct position.Connecting cables, no change in reading.Phillips monitor replicated the p2 reading.Patient taken back to ot.Catheter explanted and a new one implanted.

• Brand Name: PRESSIO® ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELING
• Common Device Name: ICP ICT 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: 22529534
• Report Number: 3001587388-2025-00061
• Device Sequence Number: 20689411
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)241128(17)290801
• 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: Physician
• Remedial Action: Replace
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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