It was reported to boston scientific corporation that a nephromax balloon catheter was used during a left percutaneous nephrolithotomy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the balloon was placed in the patient under x-ray.The balloon ruptured at the distal tip while being inflated at 18 atm of pressure using an encore inflator.There were no balloon fragments left inside the patient and the procedure was completed with another nephromax balloon catheter.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the balloon material had a longitudinal tear.
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