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

Model Number	PSO-PT
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	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending more informations and device analysis to start further investigations.
Event or Problem Description
On (b)(6) 2024, a catheter, reference pso-pt and lot number 23c42411 was implanted in a context of intracranial hypertension.On (b)(6) 2024, the device has been removed.When the practitioner checks the integrity of the explanted device, he finds that the sensor (distal metal tiptip of the pressio catheter) was missing from the end of the fiber.
Additional Manufacturer Narrative
This report is being resubmitted because the previous report sent on 05/09/2025 ((b)(4)) was not accepted.The return catheter is incomplete.The absence of the capsule detached from the pa tube indicate that the bonding romped but that this connection broke for a reason that is still unknown.A capa has been opened to find a root cause.
Event or Problem Description
On (b)(6) 2024, a catheter, reference pso-pt and lot number 23c42411 was implanted in a context of intracranial hypertension.On (b)(6) 2024, the device has been removed.When the practitioner checks the integrity of the explanted device, he finds that the sensor (distal metal tiptip of the pressio catheter) was missing from the end of the fiber.

• Brand Name: PRESSIO® INTRACRANIAL PRESSURE MONITORING KIT, PARENCHYMAL TUNNELING
• Common Device Name: PRESSIO ICP CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 21331003
• Report Number: 3001587388-2025-25045
• Device Sequence Number: 18293680
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: (01)03760124130782(11)241106(17)290601
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• 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
• Device Model Number: PSO-PT
• Device Catalogue Number: PSO-PT
• 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: 02/11/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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