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	03/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Icp values inconsistent with patient status (indicating negative values) during clinical follow-up, leading to device explantation.
Event or Problem Description
Icp values inconsistent with patient status (indicating negative values) during clinical follow-up, leading to device explantation.
Additional Manufacturer Narrative
The return catheter is compliant and operating pressure shows no anomalies.The shifted zero value (-11mmhg) is undoubtedly due to an abnormal procedure, but does not explain the problems reported in use.
Event or Problem Description
Icp values inconsistent with patient status (indicating negative values) during clinical follow-up, leading to device explantation.

• 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; besançon, 25000 ; FR 25000
• Manufacturer Contact: marion prud'homme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 19161643
• Report Number: 3001587388-2024-24118
• Device Sequence Number: 17987448
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)230531(17)280301
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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?: Yes
• 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): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: Male