AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

Additional Manufacturer Narrative

THE FAILURE ANALYSIS OF THE 3-4 CM BALLOON CONFIRMED A LONGITUDINAL TEAR ALONG THE LENGTH OF THE DEVICE AXIS CONSISTENT WITH THE BALLOON RUPTURING, WHICH CAN OCCUR IF THE BALLOON IS OVERINFLATED, DAMAGED BY A SHARP SURGICAL INSTRUMENT, OR IF THE PATIENT'S ANATOMY PLACES EXCESSIVE STRESS ON THE BALLOON. A MANUFACTURING LOT HISTORY REVIEW FOUND NO ANOMALIES RELATING TO THE FAILURE OF THE DEVICE. THUS, NO ROOT CAUSE WAS CONFIRMED.

Description of Event or Problem

A PATIENT UNDERWENT INTRAOPERATIVE RADIATION TREATMENT (IORT) FOR BREAST CANCER. THE TREATMENT FACILITY REPORTED THAT DURING THE PROCEDURE, THE BALLOON CATHETER HAD RUPTURED WHILE IMPLANTED IN THE PATIENT, THUS ALLOWING STERILE WATER TO SPILL OUT. NO ACTIVE RADIATION THERAPY WAS BEING APPLIED. THE BALLOON WAS REMOVED FROM THE PATIENT AND A NEW BALLOON WAS INSERTED. THE PATIENT PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENT AND THERE WAS NO INJURY SUSTAINED BY THE PATIENT. THE DAMAGED DEVICE WAS RETURNED TO XOFT FOR FAILURE ANALYSIS. (B)(4).