MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MANTIS? Clip; Hemostatic Metal Clip For The Gi Tract

Model Number	M00521420
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f2301 captures the additional device required.Imdrf device code a0501 captures the reportable event of detachment of device or device component.Block d4,h4: detailed product information was not provided to boston scientific corporation as it was unavailable from the customer.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) number and other product-specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that a mantis was used during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2026.During the procedure, parts of the metal fittings detached and were removed endoscopically.The anatomy location is unknown.The procedure was completed with the original device.There were no patient complications or adverse events reported 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 ; +1(914)571-6918
• MDR Report Key: 50288793
• Report Number: 3005099803-2026-03363
• Device Sequence Number: 9694703
• Product Code: PKL
• UDI-Device Identifier: 00191506023591
• UDI-Public: (01)00191506023591
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00521420
• Device Catalogue Number: M00521420
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown