FDA Adverse Event
Injury
Summary report: N
EMBOSPHERE®
MDR report key: 23851881
·
Received December 19, 2025
Report
- Report Number
- 1721504-2025-00768
- Event Type
- Injury
- Date Received
- December 19, 2025
- Date of Event
- November 3, 2025
- 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
- CH
- 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. NONCONFORMANCES 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 THROMBOTIC EVENT THAT OCCURRED IN THE PORTAL VENOUS SYSTEM FOLLOWING PSE AND REQUIRED FURTHER EVALUATION AND MANAGEMENT. NO DEVICE MALFUNCTION IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252056 | EMBOSPHERE® | EMBOLIZATION PARTICLE, NON-BIOABSORBABLE | HCG | BIOSPHERE MEDICAL, S.A. | 00884450402948 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |