Note: this report pertains to one of two speedband superview super 7 used in the same procedure.It was reported to boston scientific corporation that a speedband superview super 7 was used in the lower esophagus during an endoscopic gastroduodenoscopy (egd) procedure to treat bleeding performed on (b)(6) 2022.During the procedure, the bands were unable to deploy.They tried to tighten the string, and adjusted the cap.When they tested the device, it misfired.A second speedband superview super 7 was used; however, the same problem happened.The procedure was not completed due to this event.It was noted that there was no difficulty experienced upon setting up the devices.It was reported that the patient had blood loss but the patient was not admitted to the hospital beyond the standard of care.There were no reported patient complications as a result of this event.No further information has been obtained despite good faith efforts.
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The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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