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	Fever (1858); Sepsis (2067); Hematuria (2558); Implant Pain (4561)
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: study: capocasale, e., larini, p., mazzoni, m.P., marcato, c., valle, r.D., busi, n., monaco, d., benozzi, l., & sianesi, m.(2005).Percutaneous renal artery embolization of nonfunctioning allograft: preliminary experience.Transplantation proceedings, 37(6), 2523-2524.Https://doi.Org/10.1016/j.Transproceed.2005.06.016 was reviewed during internal quality system activities.The publication describes that the microspheres used in percutaneous renal artery embolization (prae) procedures have been associated with hematuria, and septic fever.Echocolor doppler and clinical evaluation was scheduled at discharge and repeated at the 1, 3, 6, and 12 months follow-up.Immediate technical success was achieved in all cases; no complications occurred.In 3 cases, complete resolution of the syndrome was obtained.One patient with persisting hematuria underwent angiography that disclosed a perirenal collateral circulation originating from a lumbar artery, which was successfully embolized.One patient underwent a transplant nephrectomy because of septic fever.A post-embolization syndrome of fever and graft pain was observed in 2 of the 5 cases but resolved spontaneously in 3-4 days.The average hospital stay was 6 days.At 12 months follow-up, echocolor doppler showed the same size of the kidney in 3 cases, a 30% reduction in bipolar diameter in 1, and absence of flow in all cases.
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.

• 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: 25803133
• Report Number: 9615728-2026-00091
• Device Sequence Number: 6000284
• 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: Required Intervention; Hospitalization; Disability; Other
• Patient Sex: Unknown