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

Catalog Number	S620GH/CNA
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspected device was not returned for evaluation.However, images were provided by the customer for evaluation.In the photos provided, there was no liquid in the syringe in the original packaging.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The product history record was reviewed, and no exception documents were found.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Event or Problem Description
Customer reported that there was no liquid in the syringe in the original packaging.The microsphere was found to be in a dry state, and the liquid leak was observed.No patient harm.

• 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 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL, S.A.; parc des nations- paris nord 2; 383 rue de la belle etoile, roissy 95700 ; FR 95700
• Manufacturer Contact: ms. marie-laure patucca ; parc des nations - paris nord 2; 383 rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• MDR Report Key: 25812269
• Report Number: 9615728-2026-00152
• Device Sequence Number: 12278127
• Product Code: KRD
• UDI-Device Identifier: 00884450116715
• UDI-Public: 00884450116715
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2026

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 Expiration Date: 06/23/2026
• Device Catalogue Number: S620GH/CNA
• Device Lot Number: X3263934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown