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

Model Number	PSO-PTT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The monitor showed 17 mmhg when the catheter was connected.The pic was considered to be abnormally high considering the state of the patient.
Additional Manufacturer Narrative
The return catheter showed no particular defects in appearance.A non-compliant pressure value of 17mmhg in open air is confirmed, but after erasing and perform a new zero procedure, the catheter returns to compliant pressure behavior.The conditions under which the zero was performed may have been the cause of the defect observed in use.
Event or Problem Description
The monitor showed 17 mmhg when the catheter was connected.The pic was considered to be abnormally high considering the state of the patient.

• 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: 20156652
• Report Number: 3001587388-2024-24306
• Device Sequence Number: 17202604
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)230703(17)280501
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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: 49 YR
• Patient Sex: Male