Related manufacturer ref: (b)(4).During a left atrial flutter ablation procedure, a noise issue on the catheter and also a shift, mapping, and catheter issues were experienced resulting in a clinically significant delay.During ablation in the left superior pulmonary vein, no issues were noted, however when moving to the anterior of the ridge, all four of the catheters started to shift while radiofrequency was delivered.Multiple trouble shooting steps were taken to resolve the issues during the procedure resulting in the delay.Despite the issues, the procedure was still completed and there were no adverse consequences to the patient.
|
The study data was provided and reviewed.It was reported that " the geometry doubled over itself", ¿all four of the catheters started to shift¿, and "a purple jump glitch was also noted"¿ occurred.Review of the ensite cardiac mapping system reveals behavior that is consistent with a software issue that is addressed by resuming the study.
|