MAUDE Adverse Event Report: BIOSPHERE MEDICAL S.A. EMBOSPHERE®; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	S210GH/CNA
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports the saline had leaked from the embolic microspheres when the product was opened and the liquid volume had decreased.No patient involved.A new device was used to complete the procedure.
Additional Manufacturer Narrative
This event was identified during internal quality system activities.Upon review, the manufacturer determined the event meets fda criteria for reporting.The report is being submitted to ensure accuracy and completeness of mdr files.This submission does not reflect a change in device performance or patient risk.The awareness date corresponds to when the manufacturer became aware of the event details.All information reasonably known to the manufacturer at this time has been included.No physical units were received for evaluation in relation to this; however, photographs were provided by the customer in relation with this reported event.In the photos provided, it appears to have an partially full syringe.The actual device was not returned, and the packaging was open, therefore, the cause cannot be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were found.This complaint will be used to trend for similar complaints.

• Brand Name: EMBOSPHERE®
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BIOSPHERE MEDICAL S.A.; parc des nations-paris nord 2; 383 rue de la belle etoile; roissy-en, 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL S.A.; parc des nations-paris nord 2; 383 rue de la belle etoile; roissy-en, 95700 ; FR 95700
• Manufacturer Contact: marie-laure patucca ; parc des nations paris nord 2; 383 rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• MDR Report Key: 25363726
• Report Number: 9615728-2026-00032
• Device Sequence Number: 21496139
• Product Code: KRD
• UDI-Device Identifier: 00884450098561
• UDI-Public: 00884450098561
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: S210GH/CNA
• Device Lot Number: X2991711_
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown