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	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a mantis clip was used during an endoscopy procedure on (b)(6) 2026.During the procedure, the mantis clip locked onto tissue, but the handle and spring wire broke, and manipulation of moving left and right, trying to reposition catheter, trying to bend to angle and pull trying to torque to get the clip to release.The clip ultimately was released after a reported 20 minutes of manipulation.The procedure was completed with the same device.There were no patient complications reported as a result of this event.Note: this report pertains to the second of two clips used in different procedures.
Additional Manufacturer Narrative
Block h6: imrdf code a15 captures the reportable event of difficult to release from catheter.Block h11: investigation results- the device was not returned for analysis as it was discarded; therefore, a technical analysis could not be performed.The complaint device was not returned as it was discarded therefore, product analysis could not be carried out, for this reason and due to the lack of evidence is unable to confirm the reported event.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause not established".

• 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: 24682047
• Report Number: 3005099803-2026-01077
• Device Sequence Number: 9976978
• Product Code: PKL
• UDI-Device Identifier: 00191506023607
• UDI-Public: (01)00191506023607(17)281105(10)37887959
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/24/2026

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: 0037887959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 11/06/2025
• 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