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

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	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter showed normal icp for some hours, but after x-ray the icp curve started to change and at the same time showed incredible values.Pressure gauge looked like it was sitting where it should.
Event or Problem Description
Catheter showed normal icp for some hours, but after x-ray the icp curve started to change and at the same time showed incredible values.Pressure gauge looked like it was sitting where it should.
Additional Manufacturer Narrative
Analysis: when first connected, the kt displays consistent values in the open air, reactive on contact with the membrane.After cleaning, the kt is tested in the open air for more than 24 h.Values remain consistent and stable.Conclusion: the returned catheter conforms to our specifications, with no display defects or erroneous values observed.

• Brand Name: PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING
• Common Device Name: PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING,
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 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: 17037860
• Report Number: 3001587388-2023-23083
• Device Sequence Number: 7030532
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)220930(17)270801
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K162108
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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: Required Intervention; Other
• Patient Sex: Unknown