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	Necrosis (1971); Erectile Dysfunction (4511)
Date of Event	02/26/2024
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: salet, e., crombé, a., grenier, n., marcelin, c., lebras, y., jambon, e., coussy, a., cornelis, f.H., & petitpierre, f.(2022).Prostatic artery embolization for benign prostatic obstruction: single-centre retrospective study comparing microspheres versus n-butyl cyanoacrylate.Cardiovascular and interventional radiology, 45(6), 814-823.Https://doi.Org/10.1007/s00270-022-03069-3 was reviewed during internal quality system activities.The publication describes; 1 patient with penis glans necrosis "which was a trophic disorder that resolved with local treatments".1 patient with erectile dysfunction that resolved spontaneously within months.

• 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: 25824594
• Report Number: 9615728-2026-00109
• Device Sequence Number: 21285690
• 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): 07/15/2026

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: 07/15/2026
• 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