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

Model Number	PSO-PB
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Icp catheter replacement following accidental sectioning.After insertion of the new catheter, it was connected to the monitor.The monitor began to reboot.The monitor and cables were replaced several times, without success.Icp catheter replacement was successful but required a new cranial incision.

• Brand Name: PRESSIO ICP MONITORING KIT, PARENCHYMAL WITH BOLT
• Common Device Name: ICP MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy môquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 23476514
• Report Number: 3001587388-2025-00112
• Device Sequence Number: 18724429
• Product Code: GWM
• UDI-Device Identifier: 03760124130768
• UDI-Public: (01)03760124130768(11)250411(17)300201
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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-PB
• Device Catalogue Number: PSO-PB
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: CAPA 2025-04
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male