MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. EMBOSPHERE; AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS

Catalog Number	S120GH/CNA
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
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 returned for evaluation.The complaint was confirmed; there was a crack on the luer.The root cause was determined to potentially be human error during the screwing process.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 stated that after opening the package, they found the device had leaked liquid resulting in the embosphere being dried.
Additional Manufacturer Narrative
One unit was returned by the customer and received on 05apr2024.The customer provided one photograph of the suspect device that had leaked resulting in the embosphere being dried.The photograph displayed a partially filled syringe with a crack on the luer, confirming the reported issue.A dhr review was performed and yielded no exception documents that would cause or contribute to the reported failure.No anomaly was recorded during the monitoring of unscrewing process for this batch.During packaging inspection step, no unit with cap luer lock displayed cracks.If additional information becomes available, a follow-up report will be filed.

• Brand Name: EMBOSPHERE
• Common Device Name: AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
• 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; rue de la belle etole; roissy en, 95700 ; FR 95700
• Manufacturer Contact: marie-laure patucca ; parc des nations paris nord 2; 383 rue de la belle etoile; roissy en, 95700 ; FR 95700
• MDR Report Key: 24885482
• Report Number: 9615728-2026-00006
• Device Sequence Number: 9823565
• Product Code: NAJ
• UDI-Device Identifier: 00884450403150
• UDI-Public: 00884450403150
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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: 03/20/2026
• Device Catalogue Number: S120GH/CNA
• Device Lot Number: X2636151_
• 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: 01/19/2024
• Supplement Date Received by Manufacturer: Not provided; 04/22/2024
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 04/16/2026; 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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