MAUDE Adverse Event Report: SOPHYSA SIDE INLET CSF RESERVOIR, FLAT BOTTOM SMALL MODEL/CATHETER

Model Number	RE-1021
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The physician mentions the leakage or reservoir occured on the side.Additional surgery is required to explant the reservoir and to replace it.
Additional Manufacturer Narrative
Our quality control department conducted a thorough analysis and confirmed that there was a leakage in the returned state, but it did not occur at the place of puncture marks located in the dome but occurred at the needle puncture made on the guard location.As specified in the instructions for use, punctures must always be done into the dome, not at the guard location where the silicone material does not have the ability to naturally repolymerize and self-seal.Consequently, the incident occured after a misuse of the product.
Event or Problem Description
The physician mentions the leakage or reservoir occured on the side.Additional surgery is required to explant the reservoir and to replace it.

• Brand Name: SIDE INLET CSF RESERVOIR, FLAT BOTTOM SMALL MODEL/CATHETER
• Common Device Name: SIDE INLET CSF RESERVOIR, FLAT BOTTOM SMALL MODEL/CATHETER
• Manufacturer (Section D): SOPHYSA; 5 rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besançon, 25000 ; FR 25000
• Manufacturer Contact: lucie dubois ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22725587
• Report Number: 3001587388-2025-00077
• Device Sequence Number: 8989975
• Product Code: JXG
• UDI-Device Identifier: 03760124130812
• UDI-Public: (01)03760124130812(11)240704(17)290601(10)F24070454
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: RE-1021
• Device Catalogue Number: RE-1021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 47 KG