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

Model Number ICP CATHETER

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Internal documentation shows that the catheter has been manufactured in accordance with the quality requirements and does not show any performance abnormality or any causality relationship between the reported incident and the suspected device.According to sophysa in-house process, when the catheter will be returned, it will be analysed by our quality control laboratory and a visual and functional control will be performed.

Event Description

The catheter currently implanted is producing negative readings.It is going to be explanted.(no more information provided by the reporter even after several reminders).However, this issue could have led to an absence of good monitoring for an undefined time.

• Brand Name: PRESSIO ICP MONITORING KIT, PARENCHYMAL WITH BOLT
• Type of Device: PRESSIO® ICP MONITORING KIT, PARENCHYMAL WITH BOLT
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer Contact: viviane payrou ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 10481190
• MDR Text Key: 219565346
• Report Number: 3001587388-2020-00287
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K162108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ICP CATHETER
• Device Catalogue Number: PSO-PT
• Device Lot Number: F0388
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention