MalfunctionHCF
LARIAT RS SUTURE DELIVERY DEVICE
Received Feb 20, 2026 · Event occurred Feb 4, 2026
Report 3011706110-2026-00015 · MDR key 24401548
Device
Generic name
Instrument, Ligature Passing And Knot Tying
Manufacturer
Atricure, Inc.Model number
30-06Catalog number
FG-0028-02
Lot number
157606
Product problems
- Separation Problem
Patient
71 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE INVESTIGATION IS ANTICIPATED ONCE IT HAS BEEN RECEIVED FROM THE CUSTOMER.
Description of Event or Problem
A PATIENT UNDERWENT A LARIAT PROCEDURE VIA SUB-XIPHOID APPROACH. THE LARIAT SNARE WAS STUCK IN THE EPICARDIAL SPACE AND COULD NOT BE REMOVED. DUE TO WORSENING PERICARDIAL EFFUSIONS PROCEDURAL ACCESS WAS CONVERTED TO A MEDIAN STERNOTOMY TO REMOVE THE SNARE SUTURE TRAPPED INSIDE OF THE SNARE.