MAUDE Adverse Event Report: SOPHYSA PRESSIO ICP&ICT MONITORING KIT, PARENCHYMAL WITH BOLT; PSO-PBT

Model Number PSO-PBT

Device Problem Device Sensing Problem (2917)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

The catheter was implanted the 10th of february and used normally.After the patient did ct examination, the machine showed e001 after connection.Explantation of the catheter on the 13th of february.

• Brand Name: PRESSIO ICP&ICT MONITORING KIT, PARENCHYMAL WITH BOLT
• Type of Device: PSO-PBT
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: marion prud'homme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 17016920
• MDR Text Key: 316192779
• Report Number: 3001587388-2023-23143
• Device Sequence Number: 1
• Product Code: GWM
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSO-PBT
• Device Catalogue Number: PSO-PBT
• Device Lot Number: 21D43036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 40 YR
• Patient Sex: Male