Sphere-9™ Catheter

Issue

There have been forty-six (46) reported incident reports (none of which were from Canada) where patients with a Biotronik ICD experienced induced ventricular arrhythmia (VT and/or VF) following RF ablation of cardiac tissue using the Affera Sphere-9 catheter.Sphere-9 presents a higher current flow to the ICD or CRT-D which interacts with a safety feature built into Biotronik ICDs and CRT-Ds. The higher currents of the Sphere-9 catheter during RF application proceed to an unfavorable modulation of the coupled currents (approx. 40Hz frequency) that may be conducted via the implanted leads, and result in possible VT or VF induction.

What you should do

• Contact the manufacturer if you require additional information.