It was reported to boston scientific corporation that three speedband superview super 7 devices were used in the esophagus during an esophageal variceal ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the suture wire was hidden in the ligator cap which caused difficulty setting up the device.Consequently, the bands would not deploy successfully inside the patient.The same issue occurred with the second and third speedband superview super 7 devices.The procedure was completed with another speedband superview super 7 device.There were no patient complications reported as a result of this event.
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