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

Model Number	PSO-PB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During installation of an icp sensor, the drill bit of the kit broke in the skull, during installation with the drill, resulting in a 2nd hole drilled, and larger incision and difficulties in removing the device with mobilization of the neurosurgeons.
Additional Manufacturer Narrative
This report is being resubmitted because the previous report sent on 05/28/2025 (increment 00044) was not accepted.The device was received in besançon for appraisal.A visual and functional analysis was carried out.The drill was received in two parts: one with the index stop still attached, and the other end.In fact, it is broken at the thinnest part ("core"), at the level of the cutting part.Numerous clamping marks are present on the second part.This may reflect the use of pliers.Dimensional inspection of the returned components did not reveal any anomalies that might explain brittleness, particularly in the "core" of the drill bit (breakage zone).Analysis of the traceability of the returned drilling sub-assembly revealed no problems.The last functional check was carried out on 10/13/2023.The traceability of this drilling sub-assembly shows that the drill used may have come from five different receiving batches, i.E.A total of (b)(4).However, we are not aware of any similar incidents.
Event or Problem Description
During installation of an icp sensor, the drill bit of the kit broke in the skull, during installation with the drill, resulting in a 2nd hole drilled, and larger incision and difficulties in removing the device with mobilization of the neurosurgeons.

• Brand Name: PRESSIO® INTRACRANIAL PRESSURE MONITORING KIT, PARENCHYMAL WITH BOLT
• Common Device Name: ICP 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: 21888202
• Report Number: 3001587388-2025-00018
• Device Sequence Number: 8387757
• Product Code: GWM
• UDI-Device Identifier: 03760124130768
• UDI-Public: (01)03760124130768(11)240110(17)281101
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: 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
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/23/2025
• 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 Age: 58 YR
• Patient Sex: Male