(b)(4).The returned dreamtome rx 44 was analyzed without the preloaded jagwire guidewire, and a visual evaluation noted that the cutting wire was broken, blackened, and kinked.The device was observed under magnification, and the cutting wire was blackened, and broken from the proximal pierce hole of the working length.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken, kinked, and blackened.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 there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity, which can cause a premature cutting wire fatigue, leading to a break.Additionally, a kink or bend in the cutting wire can lead to a break.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.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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It was reported to boston scientific corporation that a dreamtome rx 44 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, in the middle of the sphincterotomy, there was difficulty bowing the device.They rotated it six clicks to the right.During sphincterotomy, the cutting wire had detached and "it looked like it snapped in half." it was reported that no part of the cutting wire detached and fell into the patient.They removed the device and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
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