Note: this report pertains to one of three devices used during the same procedure.Manufacturer report # 3005099803-2015-02149 pertains to the first speedband superview super 7 device, manufacturer report # 3005099803-2015-02150 pertains to the second speedband superview super 7 device and manufacturer report # 3005099803-2015-02151 pertains to the third speedband superview super 7 device.It was reported to boston scientific corporation on july 6, 2015 that three speedband superview super 7 devices were used in the esophagus during an esophagogastroduodenoscopy (egd) and banding procedure performed on (b)(6) 2015.Patient was treated for enlarged esophageal varices with no active bleeding.According to the complainant, during the procedure, the user set up the device and then suctioned the varix using the first speedband device (manufacturer report # 3005099803-2015-02149).The handle was turned and a ¿click¿ was heard; however, the band did not move off the ligating cap onto the varix.Another band was then deployed, it was able to successfully deploy off the ligating cap but was unable to affix onto the varix.The user then tried to deploy another band and this time, the band was able to deploy successfully.Deployed another band again but was unsuccessful and the physician removed the first speedband device.A second speedband device (manufacturer report # 3005099803-2015-02150) was used and two bands were able to successfully deploy but some of the bands did not move off the kit when being deployed.The user then changed to a third speedband device (manufacturer report # 3005099803-2015-02151), a couple of bands were used; however, this device was reportedly noted not to fire properly despite having a good suction of the varix.The procedure was completed with the third speedband superview super 7 device.The patient's condition at the conclusion of the procedure was reported to be stable but the physician noted some minor bleeding during the procedure.There was no active bleeding at the end of the procedure but the physician chose to admit the patient for an overnight observation.The patient was discharged on (b)(6) 2015.
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