MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Resolution 360 ULTRA Clip; Hemostatic Metal Clip for the GI Tract

Model Number	M00521402
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 ultra clip was used in the colon during a colonoscopy procedure performed on (b)(6) 2026 for the treatment of polyps.During the procedure, the clips were able to lock and grasp onto tissue but difficult to deploy.There were no kinks in noticed in the catheters.The physician had to open and close their hand multiple times, and they tried to maneuver the inner wire.They ended up pulling the clip to get the clip to detach and it stayed on the mucosa.The procedure was completed with the original device as intended.The second clip was difficult to deploy.The clip was able to detach after opening and closing the handle multiple times.The procedure was completed with the original device as intended.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this report pertains to the first of two devices used during the same procedure.
Additional Manufacturer Narrative
Block h6: imrdf device code a15 captures the reportable event of clip difficult to release from catheter.Block h11: investigation results: the resolution 360 ultra clip was not returned for analysis; therefore, a technical analysis could not be performed.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.A similar complaint review was completed.There were no emerging trends identified that warrant further action.There is not enough evidence to determine whether the issue was induced due to the physicians technique during the procedure or was related to a device malfunction.Additionally, without proper evaluation of the device, it remains unknown the causes that contributed to the event.Based on the thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: Resolution 360 ULTRA 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: 50716039
• Report Number: 3005099803-2026-03697
• Device Sequence Number: 10005480
• Product Code: PKL
• UDI-Device Identifier: 08714729997269
• UDI-Public: (01)08714729997269(17)290421(10)39156786
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K222503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: M00521402
• Device Catalogue Number: M00521402
• Device Lot Number: 0039156786
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 04/22/2026
• 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