The exact date of the event is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).The device has not been received for analysis; 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 an rx cytology brush was used on an unknown procedure and date.According to the complainant, the sheath of the brush got broken.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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