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

Catalog Number	S820GH/C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports that when requesting the opening of the material to perform the embolization, the doctor identified that it was without its internal liquid.No additional information was provided.
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.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.The device was returned for investigation.The investigation found that the luer lock had several cracks, which caused the serum to leak.The defect was confirmed.

• 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 SA; parc des nations-paris nord 2; 383 rue de la belle etole; 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: 24831987
• Report Number: 9615728-2026-00028
• Device Sequence Number: 18447076
• Product Code: KRD
• UDI-Device Identifier: 00884450403464
• UDI-Public: 00884450403464
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: S820GH/C
• Device Lot Number: X3076480-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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