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

Model Number	PSO-PB
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	05/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Installation of pic on 01/05/25.Functional survey.Partial removal on (b)(6) 2025 with observation that the distal end remained in place/section of the opinion.No surgical revision indicated.Transfer to neurosurgery on (b)(6) 2025.(b)(6) 2025 new neurosurgeon opinion: no surgical resection.Successive follow-up scans suggest suspect a subcutaneous position, outside the cranial cavity.The patient is gw=15 with no deficit or argument underlying infection.No indication for surgical removal, which would require a further anaesthesia, removal of the flap and a hazardous search for this piece (under sterile conditions) for no clinical benefit.Should the clinical situation evolve, this position could be re-evaluated.
Additional Manufacturer Narrative
Initial: the affected device has been received by our technical teams, and an investigation is planned.
Event or Problem Description
Installation of pic on (b)(6) 2025.Functional survey.Partial removal on (b)(6) 2025 with observation that the distal end remained in place/section of the opinion.No surgical revision indicated.Transfer to neurosurgery on (b)(6) 2025.On (b)(6) 2025: new neurosurgeon opinion: no surgical resection.Successive follow-up scans suggest suspect a subcutaneous position, outside the cranial cavity.The patient is gw=15 with no deficit or argument underlying infection.No indication for surgical removal, which would require a further anaesthesia, removal of the flap and a hazardous search for this piece (under sterile conditions) for no clinical benefit.Should the clinical situation evolve, this position could be re-evaluated.
Additional Manufacturer Narrative
Initial: the affected device has been received by our technical teams, and an investigation is planned.Final: during functional check, when the incomplete returned catheter is connected to a monitor, an e001 appear.The return catheter is contamined and non compliant.(capsule missing).This case is include in an ongoing capa which concern similar cases, root cause investigation is still ongoing.

• Brand Name: PRESSIO ICP MONITORING KIT, PARENCHYMAL WITH BOLT
• 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: 22095007
• Report Number: 3001587388-2025-00046
• Device Sequence Number: 15420476
• Product Code: GWM
• UDI-Device Identifier: 03760124130768
• UDI-Public: (01)03760124130768(11)250122(17)291001
• 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: 2025
• 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): 07/02/2025

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-PB
• Device Catalogue Number: PSO-PB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/02/2025
• 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: Unknown