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	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to our quality department for analysis.The visual inspection of the product showed no non-conformities.The valve is clean, colorless liquid is visible in the reservoir and in the valve, without any deposits.We observed that upon return, the valve was adjusted on its medium operating pressure, which is consistent with the user's declaration.In addition, we observed difficulties to adjust the device, both upon return and after cleaning.Therefore, it is very likely that the valve remained on its initial setting despite the two attempts to adjust its operating pressure.Adjustment difficulties may appear during the use of the device for many reasons, which are detailed in the instruction for use of the polaris valves.In addition, the ifu provides a troubleshooting process to follow in order to counter the possible adjustment difficulties.The initial report was originally submitted in 2017 the initial report is resubmitted in january 2020 as requested by the fda.The information provided in october 2015 has not been modified except: manufacturer contact email.Type of report (30 days).
Event or Problem Description
The surgeon adjusted the valve to its fourth operating pressure, then later to its fifth operating pressure.However, upon performing an x-ray examination to confirm the adjustment, it was found that the valve was still adjusted on its initial operating pressure.

• Brand Name: POLARIS
• Common Device Name: POLARIS ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; 91400 ; FR 91400
• MDR Report Key: 11472006
• Report Number: 3001587388-2017-01707
• Device Sequence Number: 4537605
• Product Code: JXG
• UDI-Device Identifier: 03760124131307
• UDI-Public: (01)03760124131307(17)200601(10)208285/C0406
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2017

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: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: SPVA
• Device Catalogue Number: SPVA
• Device Lot Number: C0406
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 03/12/2021
• 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: 20 YR