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

Model Number	PSO-PTT
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter was implanted in patient in theatre under normal conditions.Once procedure was completed, patient was sent to the ward for monitoring at which time the console had turned off and could not be turned back on.Monitor was connected via ac power cable and had sufficient battery power.A difference catheter cable was swapped out by staff; however, the monitor still did not turn on.A second monitor was installed at which time the monitor did work for a short period of time until it turned off and could not be turned back on.Once the catheter was disconnected from the console the monitor was able to be powered back up but as soon as the catheter was reconnected the monitor turned off.
Additional Manufacturer Narrative
Pending return of the device.
Event or Problem Description
Catheter was implanted in patient in theatre under normal conditions.Once procedure was completed, patient was sent to the ward for monitoring at which time the console had turned off and could not be turned back on.Monitor was connected via ac power cable and had sufficient battery power.A difference catheter cable was swapped out by staff however the monitor still did not turn on.A second monitor was installed at which time the monitor did work for a short period of time until it turned off and could not be turned back on.Once the catheter was disconnected from the console the monitor was able to be powered back up but as soon as the catheter was reconnected the monitor turned off.

• Brand Name: PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING
• 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; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22344216
• Report Number: 3001587388-2025-00056
• Device Sequence Number: 20033575
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)250408(17)300101
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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-PTT
• Device Catalogue Number: PSO-PTT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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