MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP AND ICT MOITORING KIT, PARENCHYMAL WITH BOLT; ICP ICT MONITORING CATHETER

Model Number	PSO-PBT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending the results of traceability and device analysis.Investigations are ongoing and results are not yet available.
Event or Problem Description
Erratic and unreliable measurements on one patient: -12 + 360 icp values displayed.Replacement with a second catheter: problem persists.Third catheter that functioned normally and was still implanted on friday (b)(6) 2025.
Event or Problem Description
Erratic and unreliable measurements on one patient: -12 + 360 icp values displayed.Replacement with a second catheter: problem persists.Third catheter that functioned normally and was still implanted on friday (b)(6) 2025.
Additional Manufacturer Narrative
Initial: pending the results of traceability and device analysis.Investigations are ongoing and results are not yet available.Final: a traceability analysis has been conducted on the manufacturing file of the device.The analysis did not reveal any clue to support the defect.The return catheter is functional and compliant, with no pressure anomalies observed during measurements, temperature perfectly stable.

• Brand Name: PRESSIO ICP AND ICT MOITORING KIT, PARENCHYMAL WITH BOLT
• 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: 22202270
• Report Number: 3001587388-2025-00053
• Device Sequence Number: 17833954
• Product Code: GWM
• UDI-Device Identifier: 03760124131758
• UDI-Public: (01)03760124131758(11)250207(17)291001
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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-PBT
• Device Catalogue Number: PSO-PBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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