Catheter Cardiovasc Interv
November 2021
Background: There is a paucity of literature on safety and efficacy of various transseptal puncture (TSP) needles.
Objectives: To assess the reported mechanisms of failure, complications, and outcomes among the most frequently used transseptal needles in the United States.
Methods: We queried the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and January 2021 for reports on the most commonly used transseptal needles: NRG (Baylis Medical, Montreal, Canada), and BRK (St.