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

Model Number	PSO-PT
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), an interference problem occurs on an icp curve that also disrupted the icp measurement on the patient monitor.The hospital had established that the monitor worked properly on battery.The department mobilized 2 monitors to monitor the patient: 1 charging monitor + 1 battery-operated monitor.Finally, the patient returned to the operating room for the replacement of the catheter.
Additional Manufacturer Narrative
The catheter is returned into 2 pieces with one part of the catheter missing (the catheter was cut with a scalpel).There is a slight noise at the beginning that intensifies at the end of the recorded data.The noise during use is confirmed no functional testing can be performed since the catheter is damaged.The default cannot be reproduced.A capa is opened on this subject to find the root cause.
Event or Problem Description
On (b)(6), an interference problem occurs on an icp curve that also disrupted the icp measurement on the patient monitor.The hospital had established that the monitor worked properly on battery.The department mobilized 2 monitors to monitor the patient: 1 charging monitor + 1 battery-operated monitor.Finally the patient returned to the operating room for the replacement of the catheter.

• Brand Name: PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING
• 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; technopole temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 20266829
• Report Number: 3001587388-2024-24314
• Device Sequence Number: 11597918
• Product Code: GWM
• UDI-Device Identifier: 03760124130782
• UDI-Public: (01)03760124130782(11)240426(17)281201
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: PSO-PT
• Device Catalogue Number: PSO-PT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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