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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon reported the lcs leak during the implantation.No consequence of the patient has been reported, the device has been replaced during the surgery.
Event or Problem Description
The surgeon reported the lcs leak during the implantation.No consequence has been reported, the device has been replaced during the surgery.
Additional Manufacturer Narrative
Investigation of the returned device revealed a deep cut on the reservoir guard, resulting in material tearing and leakage.The observed damage is consistent with improper handling/manipulation of the device.No manufacturing deficiency was identified.

• 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 guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): Sophysa; rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 25159676
• Report Number: 3001587388-2026-00035
• Device Sequence Number: 9453730
• Product Code: JXG
• UDI-Device Identifier: 03760124130812
• UDI-Public: (01)03760124130812(11)251103(17)301001(10)F25110137
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• 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
• Device Model Number: RE-1021
• Device Catalogue Number: RE-1021
• Device Lot Number: F25093394
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male