PNEUMATIC INFLATOR

Additional Manufacturer Narrative

BLOCK H6: MDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF BALLOON INFLATION DEVICE INACCURATE READING.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC HAND PUMP INFLATION DEVICE WAS ATTEMPTED TO BE USED DURING A BALLOON DILATION PROCEDURE FOR ESOPHAGEAL DILATION IN THE ESOPHAGUS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PRESSURE GAUGE DID NOT FUNCTION PROPERLY. AIR LEAKAGE WAS OBSERVED, RESULTING IN THE INABILITY TO MAINTAIN PRESSURE. CONSEQUENTLY, THE GAUGE READING WAS UNRELIABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.