MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELLING; ICP (ICT) MONITORING CATHETER

Model Number PSO-PTT

Device Problem Device Sensing Problem (2917)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

The machine showed e005 after the catheter was implanted for 12 hours.

Manufacturer Narrative

The catheter in return is not compliant, error e005 is confirmed by the breakage of the temperature micro-cable in the dongle shell.Excessive and irreversible abnormal traction while using the catheter as it has been operating for 12 hours.User error confirmed.

Event Description

The machine showed e005 after the catheter was implanted for 12 hours.

• Brand Name: PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL TUNNELLING
• Type of Device: ICP (ICT) 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: 18208239
• MDR Text Key: 328964646
• Report Number: 3001587388-2023-23454
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 03760124131765
• UDI-Public: (01)03760124131765(11)220728(17)270601
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• 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: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PSO-PTT
• Device Catalogue Number: PSO-PTT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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 Sex: Male