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

Catalog Number	S420GH/C
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip was open and there was not enough fluid in the particles.There was no medical intervention or patient injury reported.
Additional Manufacturer Narrative
The suspect device is expected to be returned for evaluation.A follow up report will be submitted once the investigation and product history review are complete.

• 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: marie-laure patucca ; parc des nations - paris nord 2; 383 rue de la belle etoile; roissy 95700
• MDR Report Key: 25393245
• Report Number: 9615728-2026-00106
• Device Sequence Number: 13441504
• Product Code: KRD
• UDI-Device Identifier: 00884450403426
• UDI-Public: 00884450403426
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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 Catalogue Number: S420GH/C
• Device Lot Number: X2830808-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown