MAUDE Adverse Event Report: BIOSPHERE MEDICAL S.A.; EMBOSPHERE

Catalog Number	S020GH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fatigue (1849); Fever (1858); Hiccups (1899); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Syncope/Fainting (4411)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The publication describes multiple serious injury events summarized in aggregate form without complete patient-level detail.Therefore, the manufacturer is submitting a consolidated literature-based mdr representing the serious injury event type described in the article.Study: imamura, a., taguchi, h., takano, h., funatsu, h., nakamura, k., arimitsu, h., & chiba, s.(2021).Whole-liver transcatheter arterial chemoinfusion and bland embolization with fine-powder cisplatin and trisacryl gelatin microspheres for treating unresectable multiple hepatocellular carcinoma.Japanese journal of radiology, 39(5), 494-502.Https://doi.Org/10.1007/s11604-020-01078-1 was reviewed during internal quality system activities.The publication describes that the microspheres used in arterial chemoinfusion and bland embolization (tacbe) procedures have been associated with anorexia, nausea, fatigue, fever without neutropenia, vomiting, abdominal pain, vasovagal episode, hypotension, and hiccups.It is unknown which patients received specific embolics, thus making it difficult to determine if the merit medical device was associated with any of the documented events.Antiemetic agents, including a 5-ht3 antagonist and steroids, were prophylactically administered to reduce nausea and vomiting.All patients in the study have hepatocellular carcinoma and anorexia and fatigue could be attributed to patient condition and not the emoblics.Fever, abdominal pain, hypotension, vasovagal episode, and hiccups were noted.
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.

• Common Device Name: EMBOSPHERE
• 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: 25810539
• Report Number: 9615728-2026-00098
• Device Sequence Number: 18824775
• Product Code: KRD
• UDI-Device Identifier: 00884450402948
• UDI-Public: 00884450402948
• Combination Product (Y/N): N
• 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): 07/14/2026

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: 02/26/2024
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown