MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING; ICP MONITORING 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	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending information on product batch number to perform a batch review.
Event or Problem Description
On (b)(6) 2024, the practitioner performed an external derivation of cerebrospinal fluid ventricular or subdural fluid by transcranial approach/route.In doing so, he performs a subcutaneous tunneling with the external csf drainage system eds 3¿ codman® csf external drainage system with ventricular catheter (integra lifesciences) part no.(b)(6) and batch no.(b)(6) and attach it to the skin at various to the skin.On (b)(6) 2024, an intracranial parenchymal sensor, reference pso-pt lot number (b)(6) is implanted.During a surgery, it was replaced by the same device same device, reference (b)(4) and lot number (b)(6).On (b)(6) 2025, when the sensor (pso-pt and lot number (b)(6)) was removed, the practitioner noticed a sensation of resistance.When he checked the integrity of the explanted device, he noticed that the sensor (distal metal tip of the pressio catheter) is missing from the end of the fiber.
Additional Manufacturer Narrative
Capa 2024-03 was opened for capsule detachment on parenchymal icp catheters.Two root causes were identified: inadequate capsule cleaning prior to bonding and an unsuitable inner capsule surface for adhesive bonding.Corrective actions include improvements to the cleaning process, modification of the capsule inner surface, and reinforced in-process controls with updated follow-up criteria.First follow up attempt was sent on 04/04/2025 with additional information on product investigation.
Event or Problem Description
On (b)(6) 2024, the practitioner performed an external derivation of cerebrospinal fluid ventricular or subdural fluid by transcranial approach/route.In doing so, he performs a subcutaneous tunneling with the external csf drainage system eds 3¿ codman® csf external drainage system with ventricular catheter (integra lifesciences) part no.821730c and batch no.7449186 and attach it to the skin at various to the skin.On (b)(6) 2024, an intracranial parenchymal sensor, reference pso-pt lot number 23c42451 is implanted.During a surgery, it was replaced by the same device same device, reference pso-pt and lot number 23c42440.On (b)(6) 2025, when the sensor (pso-pt and lot number 23c42440) was removed, the practitioner noticed a sensation of resistance.When he checked the integrity of the explanted device, he noticed that the sensor (distal metal tip of the pressio catheter) is missing from the end of the fiber.

• Brand Name: PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING
• 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: 21282000
• Report Number: 3001587388-2025-25035
• Device Sequence Number: 20791187
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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-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: 01/21/2025
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/17/2026
• 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