Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.The complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.(b)(6).(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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Note: this report pertains to two cre pro gi wireguided dilation balloons and two alliance inflation syringes used during the same patient and procedure.It was reported to boston scientific corporation that two cre pro gi wireguided dilation balloons and two alliance inflation syringes were used during a procedure performed on an unknown date.According to the complainant, during the procedure, it was noticed that the balloon seemed to be inflated on the fluoroscopy; however, the needle of the syringe did not move at all.Reportedly, a second cre pro gi wireguided dilation balloon was used but the issue was not resolved.Then, a second alliance inflation syringe was used but the issue was still not resolved.The procedure was not able to be completed as another balloon device was not available for use.There were no patient complications reported as a result of this event.
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