MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA 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	Abdominal Pain (1685); Arrhythmia (1721); Dyspnea (1816); Hematoma (1884); Hyperplasia (1906); Low Blood Pressure/ Hypotension (1914); Pain (1994); Loss of Range of Motion (2032); Transient Ischemic Attack (2109); Urinary Retention (2119); Urinary Tract Infection (2120); Perforation of Vessels (2135); Dizziness (2194); Myalgia (2238); Urinary Frequency / Polyuria (2275); Dysuria (2684); Vascular Dissection (3160); Cancer (3262); Renal Impairment (4499); Unspecified Kidney or Urinary Problem (4503); Localized Skin Lesion (4542); Skin Infection (4544); Unintended Radiation Exposure (4565); Reaction to Medicinal Component of Device (4574); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Limb Pain (4836); Pelvic Pain (4865); Rhinitis (4876); Unspecified Skin and Subcutaneous Tissue Problem (4927)
Date of Event	01/08/2024
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 events described in the publication meet 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 devices were not returned for evaluation.Device lot numbers and complete patient-specific information were not available from the publication; therefore, a review of manufacturing records and complaint trending specific to the device lots 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: sapoval, m., thiounn, n., descazeaud, a., déan, c., ruffion, a., pagnoux, g., duarte, r.C., robert, g., petitpierre, f., karsenty, g., vidal, v., murez, t., vernhet-kovacsik, h., de la taille, a., kobeiter, h., mathieu, r., heautot, j.-f., droupy, s., frandon, j., vappereau, a.(2023).Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (partem): a randomised, multicentre, open-label, phase 3, superiority trial.The lancet regional health - europe, 31, 100672.Https://doi.Org/10.1016/j.Lanepe.2023.100672 was reviewed during internal quality system activities.The publication describes that at the 9 months follow-up, there were a total of 31 patients in the pae group and 21 patients in the ct group presented at least one serious injury (table 3).No hospitalization or prolongation of hospitalization induced by a serious injury related to the treatment was observed.See table 3 on page 9 of the attached article for all side effects of the procedure.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.The serious injuries are as follows: two abdominopelvic pain, one arrythmia, three arterial dissection/perforation, three balanitis, one bph increase, three dysuria, one excessive radiation dose, one foot pain, two hematoma at femoral access, one hydrocele, one myalgia, one obstructive renal insufficiency, one pain following urinary catheterization, one pain/burning during miction, four polyuria/nocturia, seventeen post-embolization syndrome, one prostatitis, one renal tumor ablation, one rhinitis, one skin melanoma, one thoracic pain, one total hip replacement, one transient ischemic attack, and one urinary tract infection.No further information is available, and it is unknown if any patients had more than one issue arise after the pae.

• Brand Name: EMBOSPHERE
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations-paris nord 2; 383 rue de la belle etole; 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: 25745643
• Report Number: 9615728-2026-00088
• Device Sequence Number: 10413660
• 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): 07/08/2026

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: 01/08/2024
• Initial Report FDA Received Date: 07/08/2026
• 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: Other
• Patient Sex: Unknown