It was reported to boston scientific corporation that an rx cytology brush was used during an endoscopic retrograde cholangiopancreatography(ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the device had to be delivered slowly through the scope's working channel because the brush was "more flimsy than usual." with difficulty, the physician was able to have the device traverse the stricture.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Reported event: difficulty accessing common bile duct.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 mdr will be filed.
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