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

Model Number	PSO-PT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The icu in cork reported a high icp value.Our after-sales manager contacted the distributor and requested that a series of checks be performed.The distributor informed us that the patient was conscious at the time the distributor replaced the monitor, but this had no effect on the icp reading.They also replaced the cables, but the displayed icp remained unchanged.They verified whether the catheter was pulled or under tension; no tension was observed.At this stage, it is difficult to determine the cause of the elevated icp value.We are currently awaiting additional information to better understand the situation.
Additional Manufacturer Narrative
Awaiting the return of the device to perform traceability analysis and device analysis.
Event or Problem Description
The icu in cork reported a high icp value.Our after-sales manager contacted the distributor and requested that a series of checks be performed.The distributor informed us that the patient was conscious at the time the distributor replaced the monitor, but this had no effect on the icp reading.They also replaced the cables, but the displayed icp remained unchanged.They verified whether the catheter was pulled or under tension; no tension was observed.At this stage, it is difficult to determine the cause of the elevated icp value.We are currently awaiting additional information to better understand the situation.The patient was awake and talking when the icp measurement was raised.
Additional Manufacturer Narrative
Awaiting the return of the device to perform traceability analysis and device analysis.Final: reported problem cannot be reproduced during investigation.The traceability analysis did not reveal any clue to support the defect.

• Brand Name: PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING
• 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; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22059721
• Report Number: 3001587388-2025-00039
• Device Sequence Number: 8478654
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: (01)03760124130782(11)250122(17)290901
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K062584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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-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: 04/28/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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: Female