EN SNARE®
Received Mar 30, 2022 · Event occurred Mar 18, 2022
Report 2032338-2022-00001 · MDR key 13957697
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
Merit Medical SystemsCatalog number
EN2006010/C
Lot number
K2148007
Product problems
- Fracture
- Material Separation
- Fracture
- Material Separation
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WILL NOT BE RETURNING FOR EVALUATION. A LOT NUMBER WAS REPORTED, AND A REVIEW OF THE MANUFACTURING HISTORY RECORD IS IN PROGRESS.
Description of Event or Problem
THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PERIPHERAL VASCULAR PROCEDURE, WHILE MANIPULATING A VASCULAR SNARE DEVICE WITH SOME DIFFICULTY DUE TO STENT STRUTS WITHIN THE PATIENT ILIAC ARTERY, PART OF THE SNARE DETACHED. SECONDARY RETROGRADE ARTERIAL ACCESS WAS ACQUIRED TO SUCCESSFULLY DEPLOY AN ADDITIONAL PERIPHERAL VASCULAR STENT, THUS JAILING THE FOREIGN BODY WITHIN THE PATIENT'S ILIAC BIFURCATION. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. 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 IDENTIFIED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE RE-OPENED.