AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

Additional Manufacturer Narrative

A DEVICE FAILURE ANALYSIS WAS NOT PERFORMED. THE HOSPITAL FACILITY HAD DISCARDED THE DEVICE. USER ERROR APPEARS TO BE AT FAULT. ACCORDING TO THE REPORTING FACILITY, THE PHYSICIAN HAD INADVERTENTLY PUNCTURED THE BALLOON WITH A SURGICAL INSTRUMENT WHILE THE DEVICE WAS IMPLANTED IN THE PATIENT. NO ACTIVE THERAPY (OR RADIATION) WAS BEING APPLIED AT THE TIME. THE DEVICE WAS EXTRACTED AND REPLACED WITH A NEW DEVICE AND THE PATIENT'S PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY WAS SUSTAINED. A MANUFACTURING LOT HISTORY SEARCH OF THE DEVICE FOUND NO RELATED ANOMALIES. FURTHER, THE DEVICE IFU (INSTRUCTIONS FOR USE) CONTAINS THE FOLLOWING PRECAUTIONARY STATEMENTS IN RELATION TO USING SURGICAL INSTRUMENTS NEAR THE VICINITY OF THE BALLOON APPLICATOR: "EXERCISE CAUTION WHEN HANDLING THE APPLICATOR BALLOON AS WELL AS THE APPLICATOR SHAFT BOTH PRIOR TO AND DURING IMPLANTATION. SILICONE IS SUSCEPTIBLE TO DAMAGE BY SHARP INSTRUMENTS, FORCEPS, SURGICAL CLIPS AND EXCESSIVE PUSHING AND PULLING." "EXERCISE EXTREME CAUTION WHEN USING THE APPLICATOR IN CONJUNCTION WITH SURGICAL MARKING CLIPS TO AVOID PUNCTURE OF THE DEVICE. SURGICAL CLIPS WHICH PROTRUDE INTO THE TREATMENT AREA MAY INCREASE THE RISK OF DAMAGE TO THE BALLOON WHEN IT IS INSERTED AND INFLATED." THE INDICATED INCIDENT HAD OCCURRED ON (B)(6) 2014 AS PART OF THE DEVICE CLINICAL STUDY, BUT WAS REPORTED TO XOFT QUALITY ASSURANCE ON (B)(6) 2017. THE LATE REPORTING OF THIS INCIDENT WAS DUE TO A COMMUNICATION FAULT OCCURRING AT THE CLINICAL SITE. CORRECTIVE ACTION HAS SINCE BEEN IMPLEMENTED AND THE REQUIRED PERSONNEL HAVE BEEN RETRAINED.

Description of Event or Problem

THE XOFT 4-5 CM BALLOON APPLICATOR WAS INADVERTENTLY PUNCTURED BY THE PHYSICIAN WHILE THE DEVICE WAS IMPLANTED IN THE PATIENT UNDERGOING INTRAOPERATIVE RADIATION THERAPY (IORT). NO RADIATION THERAPY WAS BEING APPLIED. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW DEVICE. NO PATIENT INJURY WAS SUSTAINED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. XOFT INTERNAL COMPLAINT REFERENCE #: (B)(4).