MAUDE Adverse Event Report: SOPHYSA POLARIS® SPVA KIT PREATTACHED / BO19-10

Model Number	SPVA-2010
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The physician implanted the spva-2010.In their opinion, the valve was clogged and did not function properly.No testing was performed.
Additional Manufacturer Narrative
Conclusion : considering that the ruby ball is missing at the state of return, no pressure or programming tests could be performed.The valve integrity has been compromised before it was returned for analysis.As stated in the ifu, we recommend no valve tests, to avoid biasing the investigation.Therefore, the root cause of the incident could not be determined, as the investigation is biased by manual intervenion prior to the return.

• Brand Name: POLARIS® SPVA KIT PREATTACHED / BO19-10
• Common Device Name: POLARIS® SPVA KIT PREATTACHED / BO19-10
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 25886018
• Report Number: 3001587388-2026-00068
• Device Sequence Number: 18684877
• Product Code: JXG
• UDI-Device Identifier: 03760124131314
• UDI-Public: (01)03760124131314(11)250905(17)300801
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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 Model Number: SPVA-2010
• Device Catalogue Number: SPVA-2010
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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: Other
• Patient Age: 49 YR
• Patient Sex: Male