FDA Adverse Event
Injury
Summary report: N
EMBOSPHERE®
MDR report key: 23851856
·
Received December 19, 2025
Report
- Report Number
- 1721504-2025-00773
- Event Type
- Injury
- Date Received
- December 19, 2025
- Date of Event
- December 2, 2024
- Report Date
- December 19, 2025
- Manufacturer
- BIOSPHERE MEDICAL, S.A.
- Product Code
- HCG
- UDI-DI
- 00884450402948
- PMA / PMN Number
- K181300
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
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. NON-CONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.
Description of Event or Problem · 0
A LITERATURE ARTICLE REPORTED A CTCAE GRADE 3 PULMONARY EMBOLISM OCCURRED AFTER THE PROCEDURE. THE PULMONARY EMBOLISM REQUIRED MEDICAL MANAGEMENT. NO DEVICE MALFUNCTION IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259881 | EMBOSPHERE® | EMBOLIZATION PARTICLE, NON-BIOABSORBABLE | HCG | BIOSPHERE MEDICAL, S.A. | 00884450402948 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |