MAUDE Adverse Event Report: SOPHYSA SOPHY; SOPHY ADJUSTABLE VALVE

Model Number SM8A-2010

Device Problem Device Operational Issue (2914)

Patient Problem Hydrocephalus (3272)

Event Date 03/03/2017

Event Type  malfunction  

Event Description

The valve was implanted for 1 month and the effect of the shunt was not good, even when the valve was adjusted on its lowest operating pressure.The device was changed and the shunting system is now operating properly.

Manufacturer Narrative

The device was tested following our quality control procedure.A visual control shows dry blood deposits visible inside and on the valve and the reservoir.Several marks can be seen on the connectors, probably due to the use of forceps during explantation.The functional control shows that air and alcohol cannot flow through the valve and that the valve cannot be adjusted.The pressure control turned out to be impossible to perform due to the state of return of the valve.Even after cleaning, the presence of permanent deposits prevents any pressure measurements on the valve.The state of return of the device makes it very difficult to establish the origin of the incident.The recommendation given in the ifu to return the product in sterile water was not followed therefore it was very dry and it was difficult to know whether the observed non-conformities were due to the device or its dryness.Nevertheless, considering the situation faced by the user and the particles observed inside the valve, around the inlet connector and the rotor, we can assume that the functioning difficulties were due to an obstruction of the valve, either due to the obstruction of the inlet connector by the ball, or to the impossibility to adjust the valve, due the deposits behind the rotor.Obstruction is a well-known side-effect of a shunting system, described in the ifu of the device and widely discussed in the scientific literature.

Event Description

The valve was implanted for 1 month and the effect of the shunt was not good, even when the valve was adjusted on its lowest operating pressure.The device was changed and the shunting system is now operating properly.

• Brand Name: SOPHY
• Type of Device: SOPHY 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: 6420148
• MDR Text Key: 70423353
• Report Number: 3001587388-2017-17113
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2020
• Device Model Number: SM8A-2010
• Device Catalogue Number: SM8A-2010
• Device Lot Number: C073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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): Required Intervention