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	07/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient underwent subdural hematoma drainage + intracranial hematoma drainage + intracranial pressure probe implantation.The purpose of intracranial pressure probe insertion was to monitor intracranial pressure changes and monitor the condition.On (b)(6) 2022, the patient's condition was stable, and the intracranial pressure probe was removed.There was no resistance feeling during removal, and no metal probe at the tail end was found after removal.The metal probe was a foreign body with intracranial presence, and an elective removal was planned.The metal at the end of the intracranial pressure probe loosened and fell off, causing indwelling intracranial./ give symptomatic treatment temporarily.When the titanium mesh repair is scheduled, the foreign body is explored and removed.
Additional Manufacturer Narrative
The device has been discard, and the production batch record do not show any issue.Root cause can not be find.Follow up of the case 3001587388-2024-24367 this report is being resubmitted because the previous report sent on 04/04/2025 (increment 3001587388-2025-00008) was not accepted.
Event or Problem Description
On (b)(6) 2022, the patient underwent subdural hematoma drainage + intracranial hematoma drainage + intracranial pressure probe implantation.The purpose of intracranial pressure probe insertion was to monitor intracranial pressure changes and monitor the condition.On (b)(6) 2022, the patient's condition was stable, and the intracranial pressure probe was removed.There was no resistance feeling during removal, and no metal probe at the tail end was found after removal.The metal probe was a foreign body with intracranial presence, and an elective removal was planned.The metal at the end of the intracranial pressure probe loosened and fell off, causing indwelling intracranial./ give symptomatic treatment temporarily.When the titanium mesh repair is scheduled, the foreign body is explored and removed.

• 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; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 20627919
• Report Number: 3001587388-2024-24367
• Device Sequence Number: 15316679
• Product Code: GWM
• UDI-Device Identifier: 03760124130768
• UDI-Public: 03760124130768
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PSO-PB
• Device Catalogue Number: PSO-PB
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 42 YR
• Patient Sex: Male