ENSOETM

Additional Manufacturer Narrative

BASED ON THE PROVIDED INFORMATION, THERE IS NO REASONABLE MECHANISM BY WHICH THE ENSOETM COULD CAUSE A THERMAL INSULT TO THE ESOPHAGUS NECESSARY TO CREATE A FISTULA. HOWEVER, IF THE ENSOETM WAS NOT INSERTED TO THE APPROPRIATE DEPTH, IT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT BY FAILING TO EFFECTIVELY COOL THE ESOPHAGUS.

Description of Event or Problem

THE PATIENT UNDERWENT A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION ON (B)(6) 2023 THAT UTILIZED THE ENSOETM TO COOL THE ESOPHAGUS DURING THE PROCEDURE. THE ABLATION PROCEDURE WAS NOTED TO BE SUCCESSFUL WITHOUT ANY ACUTE INCIDENTS. ON (B)(6) 2023 , THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF STROKE. WORKUP OVER THE FOLLOWING DAYS SUGGESTED THE ETIOLOGY OF THE PATIENT'S ILLNESS WAS AN ATRIOESOPHAGEAL FISTULA. THE PATIENT'S CONDITION CONTINUED TO WORSEN, AND THE PATIENT DIED ON (B)(6) 2023.