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); Urinary Retention (2119); Bladder Dysfunction (4881)
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.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.
Event or Problem Description
Study: parikh, n., keshishian, e., manley, b., grass, g.D., torres-roca, j., boulware, d., feuerlein, s., pow-sang, j.M., bagla, s., yamoah, k., & bhatia, s.(2021).Effectiveness and safety of prostatic artery embolization for the treatment of lower urinary tract symptoms from benign prostatic hyperplasia in men with concurrent localized prostate cancer.Journal of vascular and interventional radiology, 32(7), 1053-1061.Https://doi.Org/10.1016/j.Jvir.2021.03.534 was reviewed during internal quality system activities and describes 2 patients experiencing bladder spasm and 1 patient experiencing urinary retention successfully treated with alpha-blockers.One case resulted in penile meatal necrosis from nontarget embolization which met the criteria for sir grade c complication.This patient was successfully managed with supportive care and healed 6 weeks after pae.The patient was also able to successfully undergo radiation therapy without acute or chronic gu toxicity.

• 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: 25813889
• Report Number: 9615728-2026-00107
• Device Sequence Number: 5964866
• 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