(date of event): the exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The returned truetome jag 44 was analyzed, and a visual evaluation noted that the cutting wire was broken, blackened, and bent, consistent with the findings when the device was observed under magnification.A functional evaluation was not performed due to the condition of the device (broken cutting wire).No other problems with the device were noted.The product analysis revealed that the cutting wire was broken.Upon analysis, it was found that the cutting wire was broken, blackened, and bent.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been caused if the cutting wire was preactivated before use which may cause premature cutting wire fatigue and may compromise the cutting wire's integrity.Not verifying that the cutting wire if it has exited the endoscope while electrical current is applied, and not maintaining direct and constant contact with tissue when applying electrocautery current could also contribute to wire breakage, as well as excessive power which may damage the integrity of cutting wire, according to the instructions for use.It was also found that the cutting wire was bent which could have been generated when the device was withdrawn from the procedure.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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Initially it was reported that there was an unknown event with a truetome jag 44 device on an unknown date.The device was returned, and preliminary investigation results revealed that there is a break in the cutting wire.This event has now been deemed reportable and full investigation results will follow in a final report.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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