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

Model Number	M00521230
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip was used on an unknown anatomical location during a polypectomy procedure performed on(b)(6)2026.During the procedure, after the hemoclip was positioned, the device was activated and closed; however, the hemoclip was not completely released from the device, remaining partially attached to the activation wire, making it necessary to pull on it for complete release.At that moment, the hemoclip detached from the mucosa.No information regarding the procedure outcome was provided.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information, despite good faith efforts.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6) initial reporter city: (b)(6) block h6: imdrf device code a15 captures the reportable event of clip difficult to release from the 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: 50817737
• Report Number: 3005099803-2026-03849
• Device Sequence Number: 10713027
• Product Code: PKL
• UDI-Device Identifier: 08714729875628
• UDI-Public: (01)08714729875628(17)270705(10)34377235
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• 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: 0034377235
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 07/05/2024
• 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