Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.The complainant was unable to report the device lot number; therefore, the manufacture and expiration date is unknown.(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 mdr will be filed.
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It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the lungs during a bronchoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the balloon was broken.There were no patient complications reported as a result of the event.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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