MAUDE Adverse Event Report: SOPHYSA POLARIS® SPVA KIT PREATTACHED / BO19-10; SPVA-2010

Model Number	SPVA-2010
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting further information from the declarant.
Event or Problem Description
During post-operativing follow up, the valve has malfunctioned.
Additional Manufacturer Narrative
Our quality department conducted various analyses on the returned device: - visual inspection : valve is clean, a little residue is present near the ball - programming control before decontamination: the result is complied within our specification - programming control after decontamination: the result is complied within our specification the batch file has been reviewed and the valve complies with the expected specifications when release from production in conclusion, valve no.414393 returned for a deprogramming problem complies with our specifications.There were no programming issues during the tests.The root cause cannot be established.
Event or Problem Description
During post-operativing follow up, the valve has malfunctioned.

• Brand Name: POLARIS® SPVA KIT PREATTACHED / BO19-10
• Common Device Name: SPVA-2010
• Manufacturer (Section D): SOPHYSA; rue sophie germain; besancon 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besancon 25000 ; FR 25000
• Manufacturer Contact: lucie dubois ; 5 rue guy moquet; orsay 91400 ; FR 91400
• MDR Report Key: 19791857
• Report Number: 3001587388-2024-24247
• Device Sequence Number: 4149001
• Product Code: JXG
• UDI-Device Identifier: 03760124131314
• UDI-Public: (01)03760124131314(11)240228(17)290101
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: K141227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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: Other
• Patient Sex: Female