MAUDE Adverse Event Report: SOPHYSA PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING; PRESSIO® INTRACRANIAL PRESSURE MONITORING KIT, VENTRICULAR TUNNELING

Model Number	PSO-VT
Medical Device Problem Codes	Obstruction of Flow (2423); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Error in pressure measurement at any time for no apparent reason.
Additional Manufacturer Narrative
Analysis: after opening the dongle shell, there are no cut wires on the circuit board.A pull on the micro-wire inserted in the pa tube shows that it is broken in the tube.Conclusions: the return catheter does not comply with our specifications.Abnormal elongation of the pa tube into which the micro-wire is inserted caused the micro-wire to break internally, resulting in an irreversible electrical discontinuity (e001).Unknown root cause.
Event or Problem Description
Error in pressure measurement at any time for no apparent reason.

• Brand Name: PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING
• Common Device Name: PRESSIO® INTRACRANIAL PRESSURE MONITORING KIT, VENTRICULAR TUNNELING
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; EN 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: marion prud'homme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 17017175
• Report Number: 3001587388-2023-23101
• Device Sequence Number: 7126454
• Product Code: GWM
• UDI-Device Identifier: 03760124131482
• UDI-Public: (01)03760124131482(11)220922(17)270601
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PSO-VT
• Device Catalogue Number: PSO-VT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 05/29/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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: 47 YR
• Patient Sex: Female