MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELLING; ICP MONITORING CATHETER

Model Number	PSO-VT
Medical Device Problem Codes	Arcing (2583); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Four days after the catheter was implanted, the machine showed e001.
Additional Manufacturer Narrative
Error e001 confirmed with monitor.Dongle shells open, the micro-cable is broken under the electronic card.However, the shock absorber function (10 mm elongation) is compliant, no jamming or blocking of the micro-cable in the shell or under the card.The catheter has been functional for 4 days, the cable breakage is undoubtedly due to excessive and abnormal traction during use.User error.
Event or Problem Description
Four days after the catheter was implanted, the machine showed e001.

• Brand Name: PRESSIO ICP MONITORING KIT, VENTRICULAR TUNNELLING
• Common Device Name: ICP MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: marion prudhomme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 18510925
• Report Number: 3001587388-2023-23504
• Device Sequence Number: 3665227
• Product Code: GWM
• UDI-Device Identifier: 03760124131482
• UDI-Public: (01)03760124131482(11)210908(17)260901
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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 Expiration Date: 09/01/2026
• Device Model Number: PSO-VT
• Device Catalogue Number: PSO-VT
• Device Lot Number: 21C44537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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: 28 YR
• Patient Sex: Male