Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.According to the complainant, prior to the procedure the balloon was tested and was not able to hold air.It was also noticed that the tip of the balloon was bent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.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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