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.
|
It was reported to boston scientific corporation that two speedband superview super 7 devices were used in the esophagus during a band ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the first two bands successfully deployed; however, the remaining bands failed to deploy.A second speedband device was used, the first three successfully deployed but the four remaining bands deployed at the same time even without rotating the handle.The procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty in setting up the device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
|