MAUDE Adverse Event Report: SOPHYSA SOPHY MINI VALVE; ADJUSTABLE HYDROCEPHLUS VALVE

Model Number SM8A + BO19-10 + B905-S

Device Problem Device Inoperable (1663)

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

The actual nature of the event causing the doctor to explant the device is not clear at this moment.Waiting the returned place to confirm the default.

Event Description

The doctor explanted the device as it is no longer functioning.

Manufacturer Narrative

Sophysa has received the returned piece and the product in question has been examined according to our quality control procedure: visual check: colorless liquid is visible in the valve and the reservoir, deposits are present near the ruby ball and on the spring of the rotor.The reservoir is clean.The sight shows that the inlet connector is released of the valve therefore all calibrated pressures have been changed.Functional control: the valve is not stuck and could be programmed correctly without difficulty.Pressure control: pressure control is not possible as the inlet connector is released of the valve, invaliding all the calibrated pressure.The root cause of the valve default is the displacement of the inlet connector.The valve is 100% controlled (pressure/flow characteristics, visual controls, etc.) during the manufacturing process.The pressure setting is pre-calibrated and is directly related to the calibrated position of the inlet connector.The displacement of the inlet connector could not have been originated from the manufacturing process.In sophysa record, the displacement of the inlet connector has never happened in the normal use condition.Spontaneous displacement of the inlet connector is not quite possible to our knowledge.The cause of the displacement of the inlet connector could not be identified in laboratory condition.

Event Description

The doctor explanted the device as it is no longer functioning.

• Brand Name: SOPHY MINI VALVE
• Type of Device: ADJUSTABLE HYDROCEPHLUS 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: 5569740
• MDR Text Key: 42498615
• Report Number: 3001587388-2015-15385
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K013488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SM8A + BO19-10 + B905-S
• Device Catalogue Number: SM8A + BO19-10 + B905-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No Information
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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