MAUDE Adverse Event Report: SOPHYSA POLARIS® ADJUSTABLE VALVE, 10-140, ANTECHAMBER, SIPHONX®

Model Number	SPVA140-SX
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The valve spva-140 sx was explanted following concerns that the valve was not patent and csf was not drained properly.Given this concern, the doctor explanted the valve and replaced it with another one.Then the valve was working as intended.
Additional Manufacturer Narrative
Our quality department conducted various analyses on the returned device: visual inspection: compliant.Pressure testing before decontamination: not compliant for pressure 4.Programming control before decontamination: not compliant: the valve has not been returned under the recommended conditions for the programming control.Anti-siphon: compliant.In conclusion, the difficulties encountered by practitioners for csf drainage are due to the organic residues present inside the device.This is the reason why the obstruction occured for pressure 4.The obstruction is the root cause for pressure 4 non-compliancy.This phenomenon is well known and is documented in the risk analysis and the instructions for use.

• Brand Name: POLARIS® ADJUSTABLE VALVE, 10-140, ANTECHAMBER, SIPHONX®
• Common Device Name: POLARIS® ADJUSTABLE VALVE, 10-140, ANTECHAMBER, SIPHONX®
• Manufacturer (Section D): SOPHYSA; 5 rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 21227903
• Report Number: 3001587388-2025-25008
• Device Sequence Number: 8534326
• Product Code: JXG
• UDI-Device Identifier: 03760124131741
• UDI-Public: (01)03760124131741(11)200527(17)250501
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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: 05/01/2025
• Device Model Number: SPVA140-SX
• Device Catalogue Number: SPVA140-SX
• Device Lot Number: H021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male