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

Model Number	PSO-PT
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial: awaiting product return for device analysis.
Event or Problem Description
During the surgery on (b)(6) 2025, the neurosurgeon connected this consumable to the equipment, which caused the main unit to go black.The same malfunction occurred repeatedly, which affected the surgical process and posed a significant risk.After replacing with the same model probe, it functioned normally.
Event or Problem Description
During the surgery on (b)(6) 2025, the neurosurgeon connected this consumable to the equipment, which caused the main unit to go black.The same malfunction occurred repeatedly, which affected the surgical process and posed a significant risk.After replacing with the same model probe, it functioned normally.
Additional Manufacturer Narrative
Initial: awaiting product return for device analysis.Followup 1 : analysis of the catheter : general appearance normal.Displays 0 mmhg on the monitor when exposed to air; same result on several monitors (pressio1 or pressio2).Zero reading recorded on 06/26/2025; no data in memory.If left connected for more than 80 seconds, it causes the first pressio2 monitor to shut down.On another pressio2 monitor, as soon as the catheter is connected and an attempt is made to view its history, the monitor shuts down and reboots until the catheter is disconnected.Once an error occurs on a monitor, reconnecting this catheter to the same monitor systematically triggers the same reboot failure within a few seconds.Analysis of the header data reveals the abnormal presence of 0 values differing from those expected on a compliant catheter.An investigation is currently underway to determine the root cause.Catheter traceability shows no abnormalities; the last functional test in production was performed on (b)(6) 2025 and was compliant.No further observations.

• Brand Name: PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING
• 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; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22552973
• Report Number: 3001587388-2025-00064
• Device Sequence Number: 9439186
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: (01)03760124130782(11)250217(17)300101
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062584
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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-PT
• Device Catalogue Number: PSO-PT
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown