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

Model Number	PSO-VT
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial: awaiting product return for device analysis.
Event or Problem Description
A pso-vt was indicated to monitor icp in a case of traumatic brain injury.The monitor showed e001 after the implantation.This incident leads to additional surgery for the patient.The device was explanted.
Event or Problem Description
A pso-vt was indicated to monitor icp in a case of traumatic brain injury.The monitor showed e001 after the implantation.This incident leads to additional surgery for the patient.The device was explanted.
Additional Manufacturer Narrative
A kt pso-vt no.(b)(6) returned (reported as no.(b)(6)), relatively clean catheter analysis: visual: pa tube extended by 20 mm damaged area on the tube near the y-splitter; additionally, the silicone tube is abnormally deformed (indicating excessive tension on the pa tube relative to the silicone tube, a phenomenon sometimes observed during manufacturing!) doubts regarding the integrity of the internal pressure cable.Functional: when connected to a pressio monitor, the catheter displays error e001 (electrical discontinuity).Investigation: opening the dongle housing confirms a cable break beneath the circuit board; the cable is also abnormally coiled (corkscrew-like), a sign of abnormal tension/stress; the cable is not pinched beneath the board.Data analysis shows that the zero-point calibration was performed on (b)(6) 2025 (date of the reported incident), with approximately 15 minutes of data stored in memory.Since the zero-point calibration was performed during use, this catheter was subsequently damaged (abnormal excessive tension, jamming during handling??) traceability: the catheter's traceability shows nothing abnormal; the last functional test in production was performed on 02/12/2025 and was compliant.This kt originally bore the number (b)(6) but was subject to a recall in china due to suspected leakage.The unpacking, testing, and repackaging process required a new identification; this compliant kt was re-identified as (b)(6) in order to maintain traceability for the integration/adjustment and finishing stages.No further observations.

• Brand Name: PRESSIO ICP MONITORING KIT, VENTRICULAR 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: 24304498
• Report Number: 3001587388-2026-00010
• Device Sequence Number: 5315188
• Product Code: GWM
• UDI-Device Identifier: 03760124131482
• UDI-Public: (01)03760124131482(11)240108(17)281101
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162108
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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-VT
• Device Catalogue Number: PSO-VT
• Was Device Available for Evaluation?: Yes
• 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: 02/10/2026
• 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: 54 YR
• Patient Sex: Male