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

Catalog Number	S810GH/CNA
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.
Event or Problem Description
It was reported that during prep for a hepatic artery embolization, a foreign material resembling a hair was found in the syringe.This product was not used for the procedure.A new device was used instead.No injury or additional medical treatments were required as a result of this event.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.A photo of the device alleged to be involved in the reported event was provided by the account.The complaint could not be confirmed.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 device 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.

• Brand Name: EMBOSPHERE®
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BIOSPHERE MEDICAL, S.A.; parc des nations - paris nord; 383 rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL, S.A.; parc des nations - paris nord; 383 rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• Manufacturer Contact: marie-laure patucca ; parc des nations - paris nord; 383 rue de la belle etoile; roissy-en-france, 95700 ; FR 95700
• MDR Report Key: 24964576
• Report Number: 9615728-2026-00103
• Device Sequence Number: 4850260
• Product Code: KRD
• UDI-Device Identifier: 00884450106051
• UDI-Public: 00884450106051
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: S810GH/CNA
• Device Lot Number: X3263929_
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 04/29/2026
• 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