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

Model Number ICP CATHETER

Device Problems Difficult to Insert (1316); Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2017

Event Type  malfunction  

Manufacturer Narrative

The probe has not been returned by hospital.The analyze by quality control laboratory has not begun.Sophysa asked user to return the medical device in order to perform further investigation.Internal documentation shows that icp probe has been manufactured in accordance with quality requirements.Further investigation will make it possible to know the causes of the appearance of this incident.

Event Description

The icp sensor could not be plugged into catheter extension cable after being tunneled.

Manufacturer Narrative

Corrected data: the unique identifier (udi) number has been corrected according to sophysa in-house process, the probe (b)(4)/e0284 has been analyzed by the quality control department.The traceability documents do not show any performance abnormality or any causality : the product history and batch records were reviewed and documentation indicated the product met release criteria.The inspection performed on the probe shows that the catheter is clean and that connections pins are not in the axis of the electronics card.This deviation explains the appearance of this event, involving connection difficulties noted by the user.However, this deviation does not make the connection impossible but makes the manipulation a bit difficult.In addition, as indicated in the product's instructions for use, an available replacement kit is required before implantation.Finally, the catheter has not been implanted and thus, the event did not contribute to a serious injury.

Event Description

The icp sensor could not be plugged into catheter extension cable after being tunneled.

• Brand Name: PARENCHYMAL PRESSIO CATHETER
• Type of Device: ICP PRESSURE MONITORING CATHETER
• Manufacturer (Section D): SOPHYSA SA; 5, rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer Contact: jean-christophe audras ; 5, rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 6868579
• MDR Text Key: 86505849
• Report Number: 3001587388-2017-17394
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

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: 04/01/2022
• Device Model Number: ICP CATHETER
• Device Catalogue Number: PSO-PT
• Device Lot Number: E0284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2017
• 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