MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Resolution 360 Clip; Hemostatic Metal Clip For The Gi Tract

Model Number	M00521230
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip was used in the colon during a colonoscopy procedure performed on (b)(6)2026 for the treatment during a biopsy.During the procedure, the clip was able to grasp and lock onto tissue but failed to deploy.The procedure was completed with another device of a different size.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.
Additional Manufacturer Narrative
Block h6: imrdf device code a15 captures the reportable event of clip failure to release from catheter.

• Brand Name: Resolution 360 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: 50819151
• Report Number: 3005099803-2026-03852
• Device Sequence Number: 18694763
• Product Code: PKL
• UDI-Device Identifier: 08714729875628
• UDI-Public: (01)08714729875628(17)290614(10)39587480
• Combination Product (Y/N): N
• Initial Reporter Country: PR
• PMA/510(K) Number: K222503
• 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
• Report Date (Section B): 09/18/2026

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: M00521230
• Device Catalogue Number: M00521230
• Device Lot Number: 0039587480
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 06/15/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 170 LB