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

Model Number	PSO-PBT
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	Idiopathic Intracranial Hypertension (4588)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When the monitor is connected to the electrical sector, the curve becomes totally unreadable due to interferences.The curve is also unreadable when the monitor is connected to the hospital's corrugated electrical network.
Additional Manufacturer Narrative
It was requested to keep the device after explantation for analysis.
Event or Problem Description
When the monitor is connected to the electrical sector, the curve becomes totally unreadable due to interferences.The curve is also unreadable when the monitor is connected to the hospital's corrugated electrical network.
Additional Manufacturer Narrative
The catheter shows an abnormal position of the micro-wires in the capsule, with a potential risk of contact with the capsule.Functional tests show the presence of significant noise when the catheter is immersed in water (38°c), and visibly confirm a direct link with the unusual position of the micro-wires.The noise and disturbances observed in use therefore seem to be due to a faulty positioning of the micro-wires.A capa is currently under processing for this defect this report is being resubmitted because the previous report sent on 04/03/2025 (increment 00004) was not accepted.

• Brand Name: PRESSIO ICP AND ICT MONITORING 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; technopole temis; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 21227650
• Report Number: 3001587388-2025-25003
• Device Sequence Number: 8534320
• Product Code: GWM
• UDI-Device Identifier: 03760124131758
• UDI-Public: (01)03760124131758(11)240715(17)290601
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 52 YR
• Patient Sex: Male