MAUDE Adverse Event Report: SOPHYSA PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING; PRESSIO® INTRACRANIAL PRESSURE MONITORING KIT, VENTRICULAR TUNNELING

Model Number PSO-VT

Device Problems Obstruction of Flow (2423); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2023

Event Type  malfunction  

Event Description

Error in pressure measurement at any time for no apparent reason.

Manufacturer Narrative

Analysis: after opening the dongle shell, there are no cut wires on the circuit board.A pull on the micro-wire inserted in the pa tube shows that it is broken in the tube.Conclusions: the return catheter does not comply with our specifications.Abnormal elongation of the pa tube into which the micro-wire is inserted caused the micro-wire to break internally, resulting in an irreversible electrical discontinuity (e001).Unknown root cause.

Event Description

Error in pressure measurement at any time for no apparent reason.

• Brand Name: PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING
• Type of Device: PRESSIO® INTRACRANIAL PRESSURE MONITORING KIT, VENTRICULAR TUNNELING
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; EN 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: 17017175
• MDR Text Key: 316129319
• Report Number: 3001587388-2023-23101
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 03760124131482
• UDI-Public: (01)03760124131482(11)220922(17)270601
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PSO-VT
• Device Catalogue Number: PSO-VT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female