It was reported to boston scientific corporation that an rx cytology brush was opened for use on (b)(6) 2014.According to the complainant, during preparation, the brush could not be retracted into the sheath.It was reported that the bristles of the brush were pointing in a different direction than usual, leading the customer to believe that the device had been improperly assembled.The procedure was completed with another rx cytology brush.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 good.
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Reported event of brush bristles bent.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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