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

Model Number	M00521420
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imrdf code a15 captures the reportable event of difficult to release from catheter.
Event or Problem Description
It was reported to boston scientific corporation that a mantis clip was used during a colon esd procedure on (b)(6) 2026.During the procedure, the mantis clip did not detach from the sheath.The physician attempted to retract and extend the sheath several times.After a few attempts, the sheath and clip detached; however, the mantis also disengaged from the tissue.The procedure was completed with another of the same device.There were no other reported patient complications as a result of this event.

• Brand Name: MANTIS? CLIP
• 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: 25126272
• Report Number: 3005099803-2026-01693
• Device Sequence Number: 16134718
• Product Code: PKL
• UDI-Device Identifier: 00191506023591
• UDI-Public: (01)00191506023591(17)280731(10)37113653
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: M00521420
• Device Catalogue Number: M00521420
• Device Lot Number: 0037113653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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