MAUDE Adverse Event Report: SOPHSYA PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING

Model Number	PSO-VT
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The machine showed e001 after the catheter was implanted for 24hours.
Additional Manufacturer Narrative
Analysis: soiled catheter with orange-red deposits (blood) in the drainage holes and in a large part of the central channel.A suture still attached to the silicone tube.A micro-thread (connection between sensor and micro-cable) under the silicone capsule appears broken at the edge of the capsule.Conclusion: the return catheter is not compliant, with a break under the silicone of one of the micro-wires connecting the micro-cable to one of the sensor pads causing error e001.
Event or Problem Description
The machine showed e001 after the catheter was implanted for 24 hours.

• Brand Name: PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING
• Common Device Name: PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING
• Manufacturer (Section D): SOPHSYA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: marion prud'homme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 18208260
• Report Number: 3001587388-2023-23458
• Device Sequence Number: 17992511
• Product Code: GWM
• UDI-Device Identifier: 03760124131482
• UDI-Public: (01)03760124131482(11)230303(17)280101
• 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: Other Health Care Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PSO-VT
• Device Catalogue Number: PSO-VT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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
• Patient Sex: Female