During a frontal sinus surgical procedure, the balloon catheter failed.The sinus balloon did not hold the nacl and leaked/burst.There was no harm to the patient.Investigation summary: the balloon catheter was sent to the manufacturer where it was inspected.The manufacturer tested the balloon by connecting it to an inflation device filled with water under pressure, and water was leaked during inflation.The catheter was checked under microscope and a balloon burst was discovered on catheter.This facility's complaint was verified.The manufacturer reviewed the lot history records and found no anomalies related to this complaint.
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