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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of difficult to release from catheter.
Event or Problem Description
It was reported to boston scientific corporation that two mantis clip were used during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, the clips were difficult to deploy.The procedure was completed with the original device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.Note: this report pertains to one of two devices used during the same procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of difficult to release from catheter.Block h11: investigation results the returned mantis was analyzed, and visual inspection found the device returned without the clip assembly with evidence of full deployment.The microscopic examination found evidence of full deployment.The reported event of clip difficult to release from catheter was unable to be confirmed.The investigation results summary did not detect any problems related to the reported issue, clip difficult to release from catheter as the device returned fully deployed without any visible issues.It was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of clip difficult to release from catheter was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A labeling review was performed and the ifu contains detailed device information and instructions for use.There is no evidence that the device was improperly used according to the ifu, and there is no evidence of any issues with the translation, wording, or graphics of the ifu/labeling information.Based on all additional information, the most probable root cause assigned is device problem excluded.
Event or Problem Description
It was reported to boston scientific corporation that two mantis clip were used during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, the clips were difficult to deploy.The procedure was completed with the original device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.Note: this report pertains to one of two devices used during the same procedure.

• 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: 24520172
• Report Number: 3005099803-2026-00836
• Device Sequence Number: 8522837
• Product Code: PKL
• UDI-Device Identifier: 00191506023591
• UDI-Public: (01)00191506023591(17)271109(10)35251023
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/02/2026

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: 0035251023
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2024
• 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