Speedband Superview Super 7

Description of Event or Problem

It was reported to Boston Scientific Corporation that a Speedband Superview Super 7 device was used in the anus during an internal hemorrhoid ligation procedure performed on (b)(6) 2026 for the treatment of hemorrhoids.During the procedure, the band was stuck and could not be deployed. The procedure was completed with another of the same device. 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 stable.

Additional Manufacturer Narrative

Block H6:IMDRF Device code A050501 captures the reportable event of bands Failure to Deploy.Block H11: Investigation Results:The Speedband Superview Super 7 device was contaminated and not returned for analysis; therefore, a technical analysis could not be performed, and for this reason and due to the lack of evidence is unable to confirm the reported event. A review of the Device History Record (DHR) was performed. It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A Similar Complaint Review was completed. There were no emerging trends identified that warrant further action.Based on the event description and information provided by the customer there is not enough evidence to determine whether the issue was induced due to the physicians technique during the procedure or was related to a device malfunction. Additionally, based on the most relevant information for the complaint including product record review results, the device met all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process, the definitive cause of the reported issue cannot be established due to lack of evidence. Without proper evaluation of the device, it remains unknown the causes that contributed to the event.Based on the thorough review of the reported complaint, Boston Scientific has assigned an investigation conclusion code of Cause Not Established.