Date of event: date of event was approximated to 08/01/2019 as no event date was reported.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(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 an alliance inflation syringe device was used in the esophagus during a procedure performed on an unknown date.According to the complainant, during the procedure, the gauge was not giving a pressure reading upon inflation.The procedure was completed with another alliance inflation syringe device.No patient complications have been reported as a result of this 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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