OverStitch Suture Cinch

Description of Event or Problem

It was reported to Boston Scientific that a Suture Cinch was utilized during a esophageal stent fixation procedure on (b)(6) 2026.During the procedure, a fully covered metal stent was placed, and an OverStitch device was used to place the sutures. During the cinching process, the Suture Cinch handle broke and failed to cut the suture. The handle was intentionally broken, and a hemostat was used to pull the inner wire, allowing the cinch to be manually deployed and the suture to be released and cut. The procedure was completed using the original device without further complications.No patient complications were reported as a result of the event, and the patient fully recovered.

Additional Manufacturer Narrative

Block H6:IMDRF code A050702 captures the reportable event of Failure to Cut.IMDRF code F2301 captures the reportable event of Additional Device Required.