MalfunctionMMX
ENDOVASCULAR SNARE SYSTEM
Received Aug 12, 2023
Report MW5143801 · MDR key 17536918
Device
Generic name
Device, Percutaneous Retrieval
Manufacturer
Merit Medical Systems, Inc.Model number
ONE SNAREProduct problems
- Positioning Failure
- Positioning Failure
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ONE SNARE WAS ATTEMPTED TO BE USED TO RETRIEVE A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG}, BUT IT COULD NOT BE SECURED, AND ANOTHER SNARE WAS USED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).