STERLING?

Additional Manufacturer Narrative

G4 - PREMARKET / 510(K) #: K141150, K162350. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PATIENT CONDITION.

Description of Event or Problem

IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0MMX15MMX135CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.