MAUDE Adverse Event Report: SOPHYSA PRESSIO® ICP & ICT MONITORING 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	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Outliers and a difference between the monitor and the screen.Replacement of icp.
Event or Problem Description
Outliers and a difference between the monitor and the screen.Replacement of icp.
Additional Manufacturer Narrative
Analysis: the catheter displays consistent values in the open air and is reactive.Zero performed on (b)(6) 2023.Data analysis shows that the catheter operated for about 1 day before being disconnected.Several repeated connection/disconnection tests failed to reveal any fault in the monitor as observed in use.Conclusion: the return catheter is compliant with our specificaitons.

• Brand Name: PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT
• Common Device Name: ICP&ICT MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer Contact: marion prud'homme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 17254802
• Report Number: 3001587388-2023-23316
• Device Sequence Number: 7911985
• Product Code: GWM
• UDI-Device Identifier: 03760124131758
• UDI-Public: (01)03760124131758(11)230404(17)280201
• 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: 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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