(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Note: this report pertains to the second of two dreamtome rx 44 devices used during the same procedure.It was reported to boston scientific corporation that a dreamtome rx 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During procedure, upon cannulation, it was noticed that the cutting wire had an incorrect orientation when the device exited the scope, causing the cutting wire appeared to be twisted.A second dreamtome rx 44 was used; however, when it exited the scope, same problem was noticed.It was reported that the it was unknown if it was already present during unpacking as the devices were not tested before insertion.There was no visible damage to device prior to putting it through the scope and after the problem occurred.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photos of the complaint devices outside the patient were provided by the customer and it showed the devices were slightly twisted.
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