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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was requested to keep the catheter after explantation for device analysis.
Event or Problem Description
On (b)(6) 2025, foch foundation reported interference on the pressio monitor.The patient was nevertheless monitored.On (b)(6) 2025, the catheter was still implanted.
Event or Problem Description
On (b)(6) 2025, foch foundation reported interference on the pressio monitor.The patient was nevertheless monitored.On (b)(6) 2025, the catheter was still implanted.
Additional Manufacturer Narrative
This report is being resubmitted because the previous report sent on 05/09/2025 (increment (b)(4) was not accepted.Fu1 : the return catheter is non-compliant, and the noise observed in use is confirmed and explained by contact between one of the micro-cable strands and the metal edge of the capsule.This strand, whose surface varnish is damaged, leaving the metal in direct contact with the capsule, is enough to cause a disturbance (noise) on the curve.Initial case number : 3001587388-2025-25041.

• 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 moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 21282327
• Report Number: 3001587388-2025-25041
• Device Sequence Number: 15791481
• Product Code: GWM
• UDI-Device Identifier: 03760124131758
• UDI-Public: (01)03760124131758(11)241030(17)290801
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 04/09/2026
• 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 Sex: Unknown