AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK H6: IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF CANCELED PROCEDURE.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO HOT AXIOS DEVICES USED IN THE SAME PATIENT. REFER TO TRACKWISE #(B)(4) AND TRACKWISE #(B)(4) FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE INTENDED TO BE IMPLANTED TRANSGASTRIC TO TREAT WALLED-OFF NECROSIS (WON) DURING AN ENDOSCOPIC ULTRASOUND PROCEDURE (EUS) PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE CAUTERIZATION DID NOT WORK. THE PHYSICIAN DISCONNECTED ALL CABLES, RECONNECTED THEM, BUT NOTHING CHANGED. THE ENERGY WAS SET TO A HIGHER LEVEL WITH NO RESPONSE. A SECOND AXIOS WAS USED (SUBJECT OF THIS REPORT), SAME PICTURE APPEARED, STILL NO CAUTERIZATION. THE CABLES WERE SWITCHED TO CHECK FOR ANY ISSUE, BUT THE ATTEMPT WAS UNSUCCESSFUL, IT DID NOT WORK. THERE WAS NO BLANCHING TO THE SITE, AND THE DEVICE HAD NO ENERGY, SO NO PUNCTURE WAS MADE TO THE SITE. THEREFORE, THE PROCEDURE COULD NOT BE COMPLETED AND HAD TO BE CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.