Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that an rx cytology brush was used to take cell samples in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the cell samples were to be taken from the bile duct but the brush got stuck while inside of the patient and the wire inside the catheter of the brush broke.Reportedly, they had difficulty retracting the brush back inside the catheter.There were no visible issues noted with the handle.The procedure was completed with another rx cytology brush.The procedure was completed with another rx cytology brush.There were no complications reported as a result of this event.However, the risk for increased pancreatitis was reported since the patient had undergone a longer procedure time resulting to increased radiation exposure with the use of imaging devices such as x-rays.
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