MANTIS? Clip
Received Jul 28, 2026 · Event occurred Jul 2, 2026
Report 3005099803-2026-03070 · MDR key 50061385
Device
Generic name
Hemostatic Metal Clip For The Gi Tract
Manufacturer
Boston Scientific CorporationModel number
M00521420Catalog number
M00521420
Lot number
0034831538
Product problems
- Activation, Positioning or Separation Problem
- Human-Device Interface Problem
- Material Twisted/Bent
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported to Boston Scientific Corporation that a MANTIS Clip device was used in the stomach during a gastroscopy procedure performed on (b)(6) 2026.It was reported that during the procedure, the clip became bent while attempting to close an anastomotic leak measuring approximately 1 cm. The clip was able to grasp and lock onto the target tissue; however, considerable resistance was encountered during deployment and release from the catheter. After multiple attempts, the clip was successfully released. Following deployment, the clip detached from the tissue on its own. The procedure was completed with another MANTIS Clip device.There were no patient complications reported as a result of this event. The patient's condition following the procedure was reported as fully recovered.
Additional Manufacturer Narrative
Block H6:IMDRF Device code A15 captures the reportable event of Clip Difficult to Release From Catheter.