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	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated to may 1, 2026, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a15 captures the reportable event of clip difficult to detach from the catheter.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 ultra clip device was used during an unknown procedure performed on an unknown date, on an unknown anatomy.During the procedure, difficulty was observed in detaching the clip from the catheter.The procedure was completed with the original 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 ; 9145716918
• MDR Report Key: 25445436
• Report Number: 3005099803-2026-02374
• Device Sequence Number: 14894051
• Product Code: PKL
• UDI-Device Identifier: 08714729997269
• UDI-Public: (01)08714729997269(17)290210(10)38575837
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K222503
• 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,Followup
• Report Date (Section B): 06/30/2026

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: 0038575837
• 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: 05/20/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 02/11/2026
• 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