PNEUMATIC INFLATOR

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0902 CAPTURES THE REPORTABLE EVENT OF GAUGE READING INACCURATE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATOR WAS ATTEMPTED TO BE USED IN THE CARDIAC REGION DURING AN ESOPHAGEAL DILATION PROCEDURE TO TREAT ESOPHAGEAL ACHALASIA PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE WAS USED FOR A SECOND ACHALASIA DILATION PROCEDURE. IT WAS REPORT THAT AIR WAS BEING INJECTED INTO THE BALLOON; HOWEVER, THE PRESSURE GAUGE DID NOT RISE. IT WAS REPORTED THAT THERE WERE NO ALTERNATIVE PRODUCTS AVAILABLE, THEY PERFORMED THE PROCEDURE UNDER FLUOROSCOPY AND COMPLETED IT WITH THE SAME ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.