EN SNARE®
Received May 26, 2026 · Event occurred Apr 24, 2026
Report 9616662-2026-00015 · MDR key 25284889
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
Merit Medical Ireland, Ltd.Catalog number
EN2006015/CNB
Lot number
K3421976
Product problems
- Separation Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, ONE IMAGE OF THE SUSPECT DEVICE WAS PROVIDED. THE INVESTIGATION INVOLVED REVIEW OF THE IMAGE. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE PRODUCT HISTORY WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. 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
IT WAS REPORTED THAT THE TIP OF THE SNARE BROKE INSIDE A PATIENT'S BODY, DURING THE PROCESS OF GRASPING FOREIGN OBJECTS, WHICH PROLONGED THE PROCEDURE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.