EN SNARE®
Received Sep 3, 2025 · Event occurred Dec 1, 2021
Report 1721504-2025-00330 · MDR key 22952881
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Pulmonary Embolism
- Foreign Body Embolism
- Pulmonary Embolism
- Foreign Body Embolism
Narrative
Additional Manufacturer Narrative
THE SUSPECT MEDICAL DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. NO LOT NUMBER WAS PROVIDED; THUS, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AND A SEARCH OF THE COMPLAINT DATABASE COULD NOT BE PERFORMED.
Description of Event or Problem
LITERATURE ARTICLE REPORTED THAT ON DECEMBER 1, 2021 THREE PEDIATRIC CASES OF N-BCA GLUE MIGRATION DURING VENOUS MALFORMATION EMBOLIZATION REQUIRED RETRIEVAL. IN TWO CASES, EN SNARE WAS USED TO CAPTURE EMBOLIZED GLUE FRAGMENTS FROM CENTRAL VEINS. COMPLICATIONS INCLUDED INCOMPLETE RETRIEVAL WITH RETAINED GLUE, FRAGMENTATION WITH PULMONARY EMBOLIZATION, AND THE NEED FOR SUBSEQUENT ASPIRATION OR SURGICAL EXCISION. PATIENTS REMAINED CLINICALLY STABLE, THOUGH ASYMPTOMATIC PULMONARY EMBOLI WERE OBSERVED.