MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. EMBOSPHERE; Device, Vascular, for Promoting Embolization

Catalog Number	S620GH/EUA
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
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.The suspect device was not returned for evaluation.Customer provided photographs displayed all labels showing the date of manufacture and the expiry date.The printing on the box labels was less legible because of a bad print; however, the expiry date is also printed at the bottom of the label and is clear and legible.This complaint has been confirmed.This complaint will be used to trend for similar complaints.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.
Event or Problem Description
The customer reported the expiry date (year) on the product label confused the customer because it looks like 2026 instead of 2025, hence the hospital rejected and returned the unused product to distributor.

• 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-france, 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL S.A.; parc des nations paris nord 2; 383 rue de la belle etoile; roissy-en-france, 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: 24870851
• Report Number: 9615728-2026-00048
• Device Sequence Number: 15785736
• Product Code: KRD
• UDI-Device Identifier: 00884450116715
• UDI-Public: 00884450116715
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K181300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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 Expiration Date: 12/11/2025
• Device Catalogue Number: S620GH/EUA
• Device Lot Number: X2566140-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2023
• 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
• Patient Sex: Unknown