ONE SNARE®
Received Jan 28, 2026 · Event occurred Jan 2, 2026
Report 1721504-2026-00844 · MDR key 24199367
Device
Generic name
Intravascular Catheter-snare
Manufacturer
Merit Medical Ireland, Ltd.Catalog number
ONE1500/B
Lot number
K3221086
Product problems
- Material Separation
- Detachment of Device or Device Component
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND THE MARKER BAND OF THE CATHETER WAS MISSING FROM THE TIP. NO ROOT CAUSE WAS ABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND.
Additional Manufacturer Narrative
THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE ACCOUNT ALLEGES THAT WHILE USING A ONE SNARE DEVICE, THE DEVICE'S RADIOPAQUE MARKER DETACHED WHILE THE SNARE WAS IN THE PATIENT. THE DETACHED MARKER WAS UNABLE TO BE RETRIEVED AND ULTIMATELY BECAME EMBEDDED IN THE CORONARY SINUS OF THE PATIENT'S HEART. DUE TO THIS COMPLICATION, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER EVALUATION.