MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELING; ICP & ICT MONITORING CATHETER

Model Number	PSO-PTT
Medical Device Problem Codes	Signal Artifact/Noise (1036); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All the functional test performed during manufacturing and after return of the catheter show no sign of defect on the catheter.The default cannot be reproduced.The root cause has not been identified.However, further investigation are in progress to find the root cause of the problem to take quality action into a non conformity form.The risks are already been taken into account in the product risk analysis.The ratio benefit risk is still positive.
Event or Problem Description
Disturbances on the icp curve on the pressio when on power but ok when running on the batteries.Icp value jumps between 0 to 70 mmhg.The ict shown on philips patient monitor was off by as much 0,5 degrees.
Event or Problem Description
Disturbances on the icp curve on the pressio when on power but ok when running on the batteries.Icp value jumps between 0 to 70 mmhg.The ict shown on philips patient monitor was off by as much 0.5 degrees.

• Brand Name: PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELING
• 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; technopole temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 19547234
• Report Number: 3001587388-2024-24177
• Device Sequence Number: 4851713
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)230908(17)280601
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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-PTT
• Device Catalogue Number: PSO-PTT
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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 Sex: Unknown