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

Model Number	PSO-PB
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, an intracranial pressure catheter was implanted during surgery for acute left subdural hematoma.Intracranial pressure values are rapidly negative, as early as the day of implantation.On (b)(6) 2025, the catheter was removed as unreliable, and a second one was implanted on (b)(6) 2025.
Additional Manufacturer Narrative
Pending more informations and device analysis to start further investigations.
Additional Manufacturer Narrative
This report is being resubmitted because the previous report sent on 06/05/2025 (increment 00050) was not accepted.The return catheter is contaminated (implanted).The data read from the catheter memory does indeed show values close to 0 and/or slightly lower during use.Measurements taken on the return catheter after performing a new zero calibration show normal behavior, with no explanation for the questionable values read during use.The catheter therefore appears to be conform.
Event or Problem Description
On (b)(6) 2025, an intracranial pressure catheter was implanted during surgery for acute left subdural hematoma.Intracranial pressure values are rapidly negative, as early as the day of implantation.On (b)(6) 2025, the catheter was removed as unreliable, and a second one was implanted on (b)(6) 2025.

• 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 moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 21331013
• Report Number: 3001587388-2025-25044
• Device Sequence Number: 8604168
• Product Code: GWM
• UDI-Device Identifier: 03760124130768
• UDI-Public: (01)03760124130768(11)241108(17)290801
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Replace
• 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
• Operator of Device: Health Professional
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/07/2025
• 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