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

Catalog Number	S020GH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vomiting (2144); Dyskinesia (2363); Neck Pain (2433); Voice alteration (4906)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was identified during internal quality system activities involving retrospective review of literature sources.Upon review, the manufacturer determined the event meets applicable medical device reporting criteria and is submitting this report to ensure completeness of complaint and mdr documentation.This submission does not represent new information regarding device performance or a change in the known risk profile of the device.The suspect device was not returned for evaluation.Device lot information was not available from the publication; therefore, a review of manufacturing records and complaint trending specific to the device lot could not be performed.Based on the information available from the literature source, the complaint could not be confirmed, and a definitive root cause could not be determined.
Event or Problem Description
Study: cheng, k.-l., liang, k.-w., lee, h.-l., wang, h.-y., & shen, c.-y.(2023).Thyroid artery embolization of large solitary symptomatic benign thyroid nodules through transradial approach.Quantitative imaging in medicine and surgery, 13(8), 5355-5361.Https://doi.Org/10.21037/qims-22-1385 was reviewed during internal quality system activities.The publication describes the efficacy and safety of transradial access (tra) thyroid artery embolization (tae) for patients with large solitary symptomatic benign thyroid nodules.This literature article describes multiple patient events.The study alleges the microspheres used in thyroid artery embolization (tae) procedures have been associated with radial artery spasm, pain, vomiting, voice change, and neck pain.30 f radial artery spasm, pain.Intraprocedural complication with radial artery spasm was observed during catheterization, which resolved with administration of intra-arterial calcium channel blocker.42 m received oma for neck pain resolved after oral mefenamic acid treatment.No overt or subclinical hyperthyroidism and no major complications were noted.23 m neck pain and steroids for hoarseness occurred within 1 week after the procedure and resolved with conservative treatment.Experienced considerable hoarseness following tae that resolved after oral corticosteroid treatment for 7 days.33 f received oma for neck pain and vomiting resolved after oral mefenamic acid treatment.No overt or subclinical hyperthyroidism and no major complications were noted.Periprocedural complication with temporary vomiting, no neurologic symptoms or blurred vision were noted periprocedural complication with temporary vomiting.45 f neck pain resolved after oral mefenamic acid treatment.All patients were discharged on the same day.No overt or subclinical hyperthyroidism and no major complications were noted.

• 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: 25798652
• Report Number: 9615728-2026-00090
• Device Sequence Number: 14925030
• Product Code: KRD
• UDI-Device Identifier: 00884450402948
• UDI-Public: 00884450402948
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: S020GH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown