It was reported to boston scientific corporation that a dreamtome rx 44 was used in the biliary ducts during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, "the cutting line moved a lot and the station wagon did not stay in place properly.The system stretched and relaxed." when the physician pressed the pedal energizing the device to cut the papilla, it was noticed that the cutting wire was completely twisted.It was reported that the orientation of cutting wire and the catheter were both incorrect.Additionally, the entire length of the cutting wire was completely bent and unusable.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.The reported event may suggest that the orientation of the cutting wire was incorrect.
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