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

Model Number	PSO-PBT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On april 26, the patient underwent right skull decompressive craniectomy, dural tension-reduction repair, and intracranial pressure probe implantation due to cerebral hemorrhage.On the 27th, intracranial pressure monitoring showed that the value fluctuated greatly.
Event or Problem Description
On (b)(6), the patient underwent right skull decompressive craniectomy, dural tension-reduction repair, and intracranial pressure probe implantation due to cerebral hemorrhage.On the (b)(6), intracranial pressure monitoring showed that the value fluctuated greatly.
Additional Manufacturer Narrative
The return catheter is compliant, with no instability observed on the functional tests performed.In the open air, values remain stable over 72 hours.Placed in a 20 mm water column, the catheter shows the same behavior over 72 hours.

• Brand Name: PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT
• Common Device Name: ICP (ICT) MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 19458071
• Report Number: 3001587388-2024-24173
• Device Sequence Number: 18135948
• Product Code: GWM
• UDI-Device Identifier: 03760124131758
• UDI-Public: (01)03760124131758(11)231023(17)280901
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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
• Operator of Device: Health Professional
• Device Model Number: PSO-PBT
• Device Catalogue Number: PSO-PBT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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: 66 YR
• Patient Sex: Female