MAUDE Adverse Event Report: SOPHYSA SOPHY; SOPHY MINI ADJUSTABLE VALVE, 30-200

Model Number	SM8
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The valve does not function, there is no csf flow.
Additional Manufacturer Narrative
The explanted valve was returned to sophysa for analyses on (b)(4) 2016.Results were available on (b)(4) 2016.The returned valve contains some liquid and blood, with a few residues.Some scratches can be seen on the body of the valve.A blood "clot" and suture wires are accumulated around the inner connector.No important residue could be found around the ball or the spring of the valve, which could have explained a possible clog of the mechanism.Functional controls were performed following our testing protocol.The following was observed: flush was possible.The ball was not stuck.Rotation of the rotor was possible upon return but some difficulties were observed after cleaning of the valve.Pressure were measured following our testing protocol: the pressures measured for the highest and the lowest positions of the valve were slightly higher than expected; the pressures measured for the six intermediary positions are in compliance.In conclusion, the highest and lowest pressure positions show a pressure which is slightly higher than our specifications and some adjustment difficulties were observed after cleaning.However, we did not observe any obstruction of the valve, flow always remained possible.Obstruction is a known complication of a shunting system.It is described in our instructions for use.It can appear at any stage of the shunt, including for instance the catheters.We can however not make a clear affirmation as the rest of the shunting system has not been returned to us.Another possible explanation could concern the position of the valve.Upon its return, the valve was adjusted on the second position, meaning that the opening pressure could still be decreased.
Event or Problem Description
The valve does not function, there is no csf flow.

• Brand Name: SOPHY
• Common Device Name: SOPHY MINI ADJUSTABLE VALVE, 30-200
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 5935468
• Report Number: 3001587388-2016-16349
• Device Sequence Number: 402977
• Product Code: JXG
• UDI-Device Identifier: 03760124131093
• UDI-Public: 3760124131093
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2016

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
• Operator of Device: Physician
• Device Expiration Date: 09/01/2019
• Device Model Number: SM8
• Device Catalogue Number: SM8
• Device Lot Number: B0702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2016
• Supplement Report FDA Received Date: 10/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 68