MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. EMBOSPHERE; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	S020GH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	12/03/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Case report: mri detection of uterine necrosis after uterine artery embolization for fibroids reported that two hours after the procedure, the patient complained of a small amount of vaginal bleeding and typical postembolization pain that was controlled with narcotic medication.She had persistent complaints of pelvic pain, and an mri was performed after the procedure.After mri, her pain was controlled with oral medication, and she was discharged the following day with no intraprocedural complications being noted.Four days after uterine artery embolization, the patient returned to her gynecologist for evaluation.She reported severe pain.The patient was afebrile with stable vital signs.Because of the mri findings suggesting minimal uterine perfusion, along with the clinical symptoms, a total abdominal hysterectomy and bilateral salpingo-oophorectomy were performed 4 days after uterine artery embolization.The patient tolerated this procedure well and was discharged on day 3 after the operation.On gross inspection, the bivalved uterus was the size of a uterus in the 14th week of pregnancy and had a myometrial wall thickness of 5.5 cm.It contained a 5.5 × 5.5 × 4 cm submucosal mass with a tan-white-pink whorled cut surface.Microscopic examination revealed extensive necrosis of the endometrium and myometrium with a single necrotic leiomyoma.Case report address: https://ajronline.Org/doi/10.2214/ajr.183.3.1830733.
Additional Manufacturer Narrative
This event was identified during internal quality system activities.Upon review, the manufacturer determined the event meets fda criteria for reporting.The report is being submitted to ensure accuracy and completeness of mdr files.This submission does not reflect a change in device performance or patient risk.The awareness date corresponds to when the manufacturer became aware of the event details.All information reasonably known to the manufacturer at this time has been included.The suspect device was not returned for evaluation.Therefore, the complaint could not be confirmed, and 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.

• 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: 25521684
• Report Number: 9615728-2026-00143
• Device Sequence Number: 10014362
• 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: Literature,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: 12/05/2025
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female