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

Model Number	M00521400
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
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 a resolution 360 ultra clip was used during a gastroscopy procedure on (b)(6) 2026 for treatment of bleeding.During the procedure, the resolution 360 ultra clip would not come off of the catheter when the nurse released the clip.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• 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: 25391463
• Report Number: 3005099803-2026-02302
• Device Sequence Number: 5192021
• Product Code: PKL
• UDI-Device Identifier: 08714729997245
• UDI-Public: (01)08714729997245(17)290126(10)38455721
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K222503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2026

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: M00521400
• Device Catalogue Number: M00521400
• Device Lot Number: 0038455721
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Supplement Date Received by Manufacturer: 06/11/2026; 08/25/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 06/29/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2026
• 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