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	Ischemia (1942); Arteriosclerosis/ Atherosclerosis (4437)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Study: pisco, j., bilhim, t., costa, n.V., ribeiro, m.P., fernandes, l., & oliveira, a.G.(2018).Safety and efficacy of prostatic artery chemoembolization for prostate cancer[?]initial experience.Journal of vascular and interventional radiology, 29(3), 298-305.Https://doi.Org/10.1016/j.Jvir.2017.10.013 was reviewed during internal quality system activities.The publication describes a patient with a small area of bladder wall ischemia that was removed by surgery in 1 patient 6 months after chemoembolization.There was 2 cm2 of intraluminal necrotic tissue attached to the bladder wall base, without involvement of the urethra or ureters.Among the 4 patients with technical failure, 2 patients underwent unilateral chemoembolization.Two patients with technical failure underwent rp, 1 opted for brachytherapy, and the fourth patient refused any other treatment.The technical changes were from " atherosclerotic changes of both the iliac and the prostatic arteries.".
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.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.If additional information becomes available, a supplemental report will be submitted.

• 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: 25813942
• Report Number: 9615728-2026-00123
• Device Sequence Number: 5965366
• 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): 07/14/2026

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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown