MAUDE Adverse Event Report: SOPHYSA PRESSIO® ICP MONITORING KIT, PARENCHYMAL WITH BOLT; ICP MONITORING CATHETER

Model Number	PSO-PB
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Error message e001, device sensing problem.
Event or Problem Description
Error message e001, device sensing problem.
Additional Manufacturer Narrative
The return catheter is non-compliant.A break in the micro-cable in the dongle card is the cause of error e001 (device sensing problem) observed during use.An excessive and abnormal traction during use beyond the authorized length undoubtedly caused the irreversible breakage observed.

• Brand Name: PRESSIO® ICP MONITORING KIT, PARENCHYMAL WITH BOLT
• 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; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 19017632
• Report Number: 3001587388-2024-24094
• Device Sequence Number: 3825730
• Product Code: GWM
• UDI-Device Identifier: 03760124130768
• UDI-Public: (01)03760124130768(11)230131(17)271001
• Combination Product (Y/N): N
• Initial Reporter Country: AM
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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 Model Number: PSO-PB
• Device Catalogue Number: PSO-PB
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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 Age: 10 YR
• Patient Sex: Male