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 Code	Bradycardia (1751)
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
Study: sakuhara, y., nishio, s., hattanda, f., soyama, t., takahashi, b., abo, d., & mimura, h.(2019).Initial experience with the use of tris-acryl gelatin microspheres for transcatheter arterial embolization for enlarged polycystic liver.Clinical and experimental nephrology, 23(6), 825-833.Https://doi.Org/10.1007/s10157-019-01714-9 was reviewed during internal quality system activities.The publication describes that the microspheres used in transcatheter arterial embolization (tae) procedures have been associated with bradycardia and it improved after an intravenous administration of atropine."from march 2013 to may 2013, five patients (four females, one male; mean age 52.6 years, age range 35-61 years) were enrolled.Their chief complaints were markedly distended abdomen and gastrointestinal obstruction caused by the enlarged polycystic liver.The estimated volume of the whole liver before and after tae was measured using mri data in three of the five patients.In the other two patients, noncontrast-enhanced ct image data were used for the measurement, because their liver volumes were so large that the image quality was deteriorated by a magnetic field distortion and not suitable for volume measurement.All five patients successfully completed the tae.The left lobe was treated in four patients and the right in another one.Although all patients complained of abdominal pain during and after the tae, they were relieved of the pain by the administration of analgesics.Bradycardia occurred in the first patient during the procedure, but it improved after an intravenous administration of atropine (table 1).Thereafter, the remaining four patients received a routine prophylactic administration of atropine before tae.Transient elevations of wbc, ast, alt occurred in all five patients, but the elevations improved within 7 days (table 2).A transient elevation of t-bil occurred in three patients and a transient elevation of alp occurred in one of these three patients at 7 days after tae, but these elevations also improved without any additional treatment (table 2).No patients developed hepatic insufficiency or severe com plications after tae.".

• 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: 25824551
• Report Number: 9615728-2026-22108
• Device Sequence Number: 21428472
• Product Code: KRD
• UDI-Device Identifier: 00884450402948
• UDI-Public: 00884450402948
• Combination Product (Y/N): N
• 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): 07/15/2026

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: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Female