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

Model Number	SPVA-2010
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The valve does not drain.
Additional Manufacturer Narrative
Since the valve did not drain during the initial surgery for valve implantation, this case is finally not considered reportable.Code f1903 has been replaced by f1908 as the product has not been explanted as it has not been implanted.Our quality department conducted various analyses on the returned device : visual inspection: the valve was returned quite clean, immersed in water.The valve was set to position p3.Organic residues were observed inside the valve chamber.The preconnected reservoir is deformed, exhibiting an elongated shape rather than a circular one and its internal components had been disassembled pressure testing : the valve was not compliant; an increase was observed for all pressure values between the values after production release and the values after return.However, all pressure values were compliant (including in tolerance range) except for the pressure p3, which was at 130 mmh2o, exceeding the maximum of 125 mmh2o.Programming testing: the valve was compliant.The batch file has been reviewed and the valve complies with the expected specifications when release from production.All pressure values increased compared to when the valve was released from production, and only one pressure position (p3) was not compliant.However, this non-conformity does not explain the malfunction.Indeed, the valve airflow and reservoir airflow tests are complaints.The flow circulates well in the valve, but the issue was that the valve did not drain.In conclusion, the valve is non-compliant with our specifications.The pressure increase observed across all positions - from the end of production to the return state - may be linked to the disassembly of internal reservoir components and the improper positioning of the reservoir guard that may have partially obstructed the outlet during testing, thereby increasing flow resistance.Traceability records confirm that the reservoir was correctly assembled during production.The root cause of this incident is misuse of the device by the user.Based on our experience in the field, one plausible hypothesis is that the distal tip of the peritoneal catheter became obstructed - either clogged or pressed against tissue following tunneling - resulting in elevated pressure.
Event or Problem Description
The valve did not drain during the initial surgery for valve implantation.Although the valve was not implanted, the shunt system was connected to the patient's cerebrospinal fluid (csf).

• 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; technopole temis; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 21917349
• Report Number: 3001587388-2025-00025
• Device Sequence Number: 8669431
• Product Code: JXG
• UDI-Device Identifier: 03760124131314
• UDI-Public: (01)03760124131314(11)240814(17)290701
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SPVA-2010
• Device Catalogue Number: SPVA-2010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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 Sex: Unknown