MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP AND ICT MONITORING KIT, VENTRICULAR TUNNELING; ICP ICT MONITORING CATHETER

Model Number	PSO-VTT
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial: pending more information to perform a batch review and awaiting product return for device analysis.
Event or Problem Description
A physician reported leak case observed on a pso-vt.This leads to remove and replace external derivation.No apparent technical error during device installation.
Additional Manufacturer Narrative
Initial: pending more information to perform a batch review and awaiting product return for device analysis.Final: the potential hypotheses do not allow any clear conclusion as to the origin of the perforation.The risk is already identified in the product risk analysis.The frequency of occurrence of the incident is not superior to the one estimated in the risk analysis.The risk level is therefore unchanged and the benefit risk ratio remains favorable for the patient.
Event or Problem Description
A physician reported leak case observed on a pso-vtt.This leads to remove and replace external derivation.No apparent technical error during device installation.

• Brand Name: PRESSIO ICP AND ICT MONITORING KIT, VENTRICULAR 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: 22675414
• Report Number: 3001587388-2025-00072
• Device Sequence Number: 13123560
• Product Code: GWM
• UDI-Device Identifier: 03760124131772
• UDI-Public: (01)03760124131772(11)240517(17)290401
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K162108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/13/2025

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-VTT
• Device Catalogue Number: PSO-VTT
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2024
• 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 Age: 36 YR
• Patient Sex: Male