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

Model Number	PSO-PTT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Pt has icp sensor implanted for 3 days no issues.However post a roll ( repositioning the pt) the monitor was showing negative icp values or periodically no wave form/values.The nurse and equipment nurse trouble shooted with a different connection cable and different monitors and was still receiving the same issue.No error message was displayed on the monitor.They then used a transducer from the evd to obtain an icp value.Equipment nurse called me at 1550 to let me know and help with trouble shooting, they had done all they could and what was needed to be done.I said it was likely due to the sensor being dislodged however strange there wasn't an error message.Sensor was explanted later that day.
Event or Problem Description
Pt has icp sensor implanted for 3 days no issues.However, post a roll (repositioning the pt), the monitor was showing negative icp values or periodically no wave form/values.The nurse and equipment nurse trouble shooted with a different connection cable and different monitors and was still receiving the same issue.No error message was displayed on the monitor.They then used a transducer from the evd to obtain an icp value.Equipment nurse called me at 1550 to let me know and help with trouble shooting, they had done all they could and what was needed to be done.I said it was likely due to the sensor being dislodged however strange there wasnt an error message.Sensor was explanted later that day.
Additional Manufacturer Narrative
Zero procedures performed on (b)(6)2025.Record of 5 days of monitoring.Coherent values for 3 days.At the forth day, drop of the pressure to almost 0mmhg.At the fifth day, presence of negative values.Analysis of the incriminated device: visual aspect: several bending of the catheter, cross-cut of the tube at approximately 50 mm from the edge, the internal cables are visible.Functionnal: during functional test, rapid drift and error message e001 (due to the cut in the tube).Traceability: no data supporting the incident.Based on the condition of the returned catheter, it is impossible to conclude that the catheter failed during use.

• Brand Name: PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELING
• Common Device Name: ICP & ICT 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 môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 23254736
• Report Number: 3001587388-2025-00091
• Device Sequence Number: 10414190
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)250625(17)300401
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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-PTT
• Device Catalogue Number: PSO-PTT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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: Unknown