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

Model Number	PSO-PBT
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, after removing a subdural hematoma (bilateral) from a man in his 50s who had sustained a head injury in a fall, a pso-pbt was inserted using a tunneling technique.5 days of ict/icp monitoring was performed, and on (b)(6) 2025, a doctor, the primary surgeon, attempted to remove it.During the removal procedure, a portion of the catheter got caught in the surgical field, and the catheter itself could not be removed.
Additional Manufacturer Narrative
Pending more informations to start further investigations.
Additional Manufacturer Narrative
This report is being resubmitted because the previous report sent on 04/17/2025 (increment 25046) was not accepted.A pso-pbt catheter, no.(b)(6), returned relatively clean.No clamping marks on the tube as the catheter is apparently tunnelled.No capsule, pa tube greatly elongated (approx.100 mm), glue cone still present but deformed due to elongation.Catheter zero achieved on (b)(6) 2024 (implantation announced on (b)(6) 2025), 5.2 days of measurements up to (b)(6) 2024, (explantation on (b)(6) 2025), average very low and close to 0 mmh monitor error e001.The catheter having been in use for several days, it is obvious that excessive and abnormal traction occurred at the time of explantation.No other observations.
Event or Problem Description
On (b)(6) 2025, after removing a subdural hematoma (bilateral) from a man in his 50s who had sustained a head injury in a fall, a pso-pbt was inserted using a tunneling technique.5 days of ict/icp monitoring was performed, and on (b)(6) 2025, a doctor, the primary surgeon, attempted to remove it.During the removal procedure, a portion of the catheter got caught in the surgical field, and the catheter itself could not be removed.

• Brand Name: PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
• Common Device Name: ICP AND 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: 21383531
• Report Number: 3001587388-2025-25046
• Device Sequence Number: 21019301
• Product Code: GWM
• UDI-Device Identifier: 03760124131758
• UDI-Public: (01)03760124131758(11)230526(17)280401
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• 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-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: 02/04/2025
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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: Male