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

Model Number	M00521421
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
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: imrdf code a15 captures the reportable event of failure to release from catheter.
Event or Problem Description
It was reported to boston scientific corporation that two mantis clips were used during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, the handle springs popped out and prevented the clips from deploying.Note: this report pertains to one of two devices used during the same procedure.No additional information despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that two mantis clips were used during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, the handle springs popped out and prevented the clips from deploying.The procedure was completed with unknown device.The patient's condition at the conclusion of the procedure was reported to be unknown.Note: this report pertains to one of two devices used during the same procedure.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imrdf code a15 captures the reportable event of failure to release from catheter.Block h11: investigation results the mantis was not returned for analysis; therefore, a technical analysis could not be performed.A risk review was completed and confirmed that the event of clip failure 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 review was completed of the device history record (dhr) for the device.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.Based on the thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.

• 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: 24400557
• Report Number: 3005099803-2026-00663
• Device Sequence Number: 8168242
• Product Code: PKL
• UDI-Device Identifier: 00191506023607
• UDI-Public: (01)00191506023607(17)281204(10)38117862
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 0038117862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/12/2026
• Date Device Manufactured: 12/05/2025
• 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