MAUDE Adverse Event Report: SOPHYSA POLARIS; POLARIS ADJUSTABLE VALVE

Model Number	SPVA
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sophysa has received the returned piece and the product in question has been examined according to our quality control procedure: visual check: valve in original packaging, in position 5.Pressure control: the valve has been tested through the shell by 2 different operators according to our testing procedure (from position l to h then from position h to l).During these tests, we observed difficulties of programming even if programming was possible after several tests.The valve is 100% controlled (pressure/flow characteristics, visual controls, etc.) during the manufacturing.A review of the fabrication record showed no anomalies.The valve doesn't meet its specifications concerning pressure setting.
Event or Problem Description
The adjustable valve could not be adjusted in its sterile packaging.It has not been implanted, and was returned to the manufacturer in its original packaging.

• Brand Name: POLARIS
• Common Device Name: POLARIS ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 5942479
• Report Number: 3001587388-2016-16200
• Device Sequence Number: 13783013
• Product Code: JXG
• UDI-Device Identifier: 03760124131307
• UDI-Public: 3760124131307
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K141227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2016

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: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: SPVA
• Device Catalogue Number: SPVA
• Device Lot Number: C0231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2016
• Initial Report FDA Received Date: 09/12/2016
• 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: Other