MAUDE Adverse Event Report: SOPHYSA SA PARENCHYMAL PRESSIO CATHETER; ICP PRESSURE MONITORING CATHETER

Model Number ICP CATHETER

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2018

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 event and the suspected device.The probe will be analyzed by our quality department and investigation will make possible to know the cause of the incident.

Event Description

The icp probe placed on the patient gave fluctuating icp results.The catheter was changed but still did not function properly which required the implantation of a third probe.

• Brand Name: PARENCHYMAL PRESSIO CATHETER
• Type of Device: ICP PRESSURE MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA SA; 5, rue guy moquet; orsay, cedex, 91400 ; FR 91400
• Manufacturer Contact: jean-christophe ; 5, rue guy moquet; orsay, cedex, 91400
• MDR Report Key: 7482489
• MDR Text Key: 107475779
• Report Number: 3001587388-2018-18112
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K162108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/01/2022
• Device Model Number: ICP CATHETER
• Device Catalogue Number: PSO-PB
• Device Lot Number: E0717
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2017
• 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