MAUDE Adverse Event Report: SOPHYSA SOPHY; SOPHY® SM8 ADJUSTABLE VALVE / ANTECHAMBER

Model Number	SM8A
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported a suspicion of hypodrainage due to a failure of the valve (tested intraoperatively).
Additional Manufacturer Narrative
The returned device met all its specifications.The valve is 100% controlled (pressure/flow characteristics, visual controls, etc.) during the manufacturing.A review of the fabrication record showed no anomalies.Therefore, we cannot state on the issue encountered by the user, as it could not be recreated.A possible explanation could be found in the adjustment of the valve.Upon return, we noticed that the rotor was set on the medium position, which is confirmed by the user's declaration.Lowering the operating pressure could have restored a good csf flow, but there is no indication that the user tried to adjust the valve on another pressure.
Event or Problem Description
The user reported a suspicion of hypodrainage due to a failure of the valve (tested intraoperatively).

• Brand Name: SOPHY
• Common Device Name: SOPHY® SM8 ADJUSTABLE VALVE / ANTECHAMBER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 6127168
• Report Number: 3001587388-2016-16416
• Device Sequence Number: 16378103
• Product Code: JXG
• UDI-Device Identifier: 03760124131215
• UDI-Public: 3760124131215
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2017

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
• Operator of Device: Physician
• Device Expiration Date: 09/01/2020
• Device Model Number: SM8A
• Device Catalogue Number: SM8A
• Device Lot Number: 210516
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2016
• Supplement Report FDA Received Date: 01/02/2017
• 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: Other
• Patient Age: 48 YR