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	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The physician implanted the bo19-10 and he found there was no csf.He pulled out the catheter and found the marking point was incorrect.After checking the catheter, it was found that the marking points on the catheter are opposite.
Event or Problem Description
The physician implanted the bo19-10 and he found there was no csf.He pulled out the catheter and found the marking point was incorrect.After checking the catheter, it was found that the marking points on the catheter are opposite.

• Brand Name: POLARIS® SPVA KIT PREATTACHED / BO19- 10
• Common Device Name: POLARIS® SPVA KIT PREATTACHED / BO19-10,
• Manufacturer (Section D): SOPHYSA; 5 rue guy môquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopôle temis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy môquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22736559
• Report Number: 3001587388-2025-00078
• Device Sequence Number: 18417962
• Product Code: JXG
• UDI-Device Identifier: 03760124131314
• UDI-Public: (01)03760124131314(11)241129(17)291101
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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 Model Number: SPVA-2010
• Device Catalogue Number: SPVA-2010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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 Age: 42 YR
• Patient Sex: Male