MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MANTIS; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	M00521421
Medical Device Problem Codes	Premature Activation (1484); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable investigation result of clip premature deployment at unknown anatomy location.Block h11: the returned mantis device was analyzed.The device was returned with the clip assembly detached, both arms bent, and clear evidence of premature deployment, as the yoke remained attached to the control wire; microscope inspection further confirmed the premature deployment and the bending of both arms.No other problems with the device were noted.During product analysis, the device was found with the clip assembly detached, both arms bent, and signs of premature deployment.The bending of the clip arms was likely caused by procedural or manipulation-related factors.Evidence suggests that the customer may have attempted to grasp more tissue than the clip was designed to accommodate, leading to deformation of the distal section of the clip arms and impairing proper closure and tissue attachment.Additionally, the premature deployment may have resulted from operational factors during the procedure, such as attempts to reopen the clip after activation, the physician's deployment technique, the scope's position or angle, or inadvertent capsule detachment due to contact with a surface.Based on all available information, the probable root cause assigned is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a mantis was used during an unknown procedure performed on (b)(6) 2026.It was reported that the mantis failed to deploy; it was confirmed that the clip unable to grasp/close onto tissue.The procedure was completed with another mantis.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of clip premature deployment at an unknown anatomy location.Please see block h11 for full investigation details.

• Brand Name: MANTIS
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24445867
• Report Number: 3005099803-2026-00732
• Device Sequence Number: 13372867
• Product Code: PKL
• UDI-Device Identifier: 00191506023607
• UDI-Public: (01)00191506023607(17)281002(10)37615542
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K221124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00521421
• Device Catalogue Number: 2142
• Device Lot Number: 0037615542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown