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	Pain (1994); Urinary Tract Infection (2120)
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
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: study: frandon, j., bey, e., hamard, a., mohammad, h., gonzalez, s., greffier, j., chevallier, t., de forges, h., beregi, j.-p., & droupy, s.(2021).Early results of unilateral prostatic artery embolization as a focal therapy in patients with prostate cancer under active surveillance: cancer prostate embolisation, a pilot study.Journal of vascular and interventional radiology, 32(2), 247-255.Https://doi.Org/10.1016/j.Jvir.2020.10.002 was reviewed during internal quality system activities.The publication describes the microspheres used in prostatic artery embolization (pae) procedures that have been associated with urinary infection, pain, and access site hematoma.Embolization was successfully achieved in all patients; prostate ischemia was confirmed on multiparametric mr imaging, and no off-target ischemia was reported.No major complications were reported.Two patients that experienced adverse events.Patient 3- reported a grade ii urinary infection on day 3 which was successfully treated with ofloxacine (200 mg) twice a day for 10 days.Patient 5- reported a grade i prostatic pain just after embolization, which resolved within 5 days following treatment with prednisolone (20 mg) combined with omeprazole (20 mg) once a day and paracetamol (1000 mg) 4 times a day.

• 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: 25802108
• Report Number: 9615728-2026-00093
• Device Sequence Number: 9054224
• 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: 02/26/2024
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown