Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and 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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It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during a procedure performed on an unknown date.According to the complainant, when the balloon was unpacked, it was already kinked and damaged.No patient complications have been reported as a result of this event.
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