STERLING

Description of Event or Problem

IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED AND THE PROCEDURE WAS CANCELLED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SHUNT. AN 8.0MMX40MMX40CM (4F) FG STERLING, BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT THE RATED BURST PRESSURE (RBP). THE DEVICE REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PROCEDURE IS PLANNED TO BE PERFORMED AGAIN AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

Additional Manufacturer Narrative

BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PATIENT CONDITION.