MAUDE Adverse Event Report: SOPHYSA POLARIS; POLARIS ADJUSTABLE VALVE

Model Number SPV

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Hydrocephalus (3272)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

The problem is related to the ifus.

Event Description

Devices were delivered to (b)(6) with non-conforming ifus (20 products in total).A picture describing the valve was missing.The issue was noted and reported by our quality department after delivery of the devices to the distributor.The devices have not been delivered to the end user.New ifus were delivered to the distributor for an exchange of documents.

• Brand Name: POLARIS
• Type of Device: POLARIS ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer Contact: jean-christophe audras ; 5 rue guy moquet; orsay, 91400 ; FR 91400 ; 3169353500
• MDR Report Key: 6692244
• MDR Text Key: 79267818
• Report Number: 3001587388-2017-17161
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K031097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SPV
• Device Catalogue Number: SPV
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2017
• 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