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

Model Number	M00521420
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a mantis clip was used during a procedure on (b)(6) 2026, to close a stomach fistula.It was reported that during the procedure, the mantis clip arm broke off which did not allow proper deployment.The mantis clip was released inside the patient due to the inability to remove it through the endoscope working channel.The procedure was rescheduled as they did not have backup devices to complete the case.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the event of cancelled or rescheduled procedure post sedation.Block h11: the complaint device was not returned therefore, product analysis could not be performed, 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 the event description and information provided by the customer there is not enough evidence to determine whether the issue was due to the physician's technique during the procedure or was related to a device malfunction.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause not established".

• 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: 25164848
• Report Number: 3005099803-2026-01880
• Device Sequence Number: 13417835
• Product Code: PKL
• UDI-Device Identifier: 00191506023591
• UDI-Public: (01)00191506023591(17)270201(10)33342924
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 07/06/2026

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: 0033342924
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 07/06/2026
• Date Device Manufactured: 02/02/2024
• 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