(initial reporter city): (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure 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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It was reported to boston scientific corporation that a stonetome was used in the papilla during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the cutting wire got separated.Reportedly, no part of the device was detached inside the patient.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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