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

Catalog Number	S210GH/CNA
Medical Device Problem Codes	Fracture (1260); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
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 customer reported an embolization procedure was performed after angiography and the embosphere was suspended in accordance with standard procedure.While connecting the 3-way y valve for injection by small syringe, it was note that the luer joint was cracked.The suspect device was not returned for evaluation because the patient had hepatitis b.The customer provided two photographs that exhibit the cracked luer joint.It was not possible to provide the cause of the reported issue; therefore, the complaint was not confirmed.A dhr review was performed and yielded no exception documents that would cause or contribute to the reported failure.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.If additional information becomes available, a follow-up report will be submitted.
Event or Problem Description
The customer reported an embolization procedure was performed after angiography and the embosphere was suspended in accordance with standard procedure.While connecting the 3-way y valve for injection by small syringe, it was note that the luer joint was cracked.

• 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 etole; roissy-en-france, 97500 ; FR 97500
• 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: 24909512
• Report Number: 9615728-2026-00009
• Device Sequence Number: 15902671
• Product Code: KRD
• UDI-Device Identifier: 00884450403174
• UDI-Public: 00884450403174
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 01/12/2026
• Device Catalogue Number: S210GH/CNA
• Device Lot Number: X2588762_
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• 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