MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 ULTRA CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	M00521401
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
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 clip was used during a gastroscopy procedure on (b)(6) 2026 for polyp removal.During the procedure, the resolution 360 ultra clip would not release during attempted deployment.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imrdf code a15 captures the reportable event of failure to release from catheter.Block h11: investigation results the device was not returned for analysis; therefore, a technical analysis could not be performed.The complaint device was not returned therefore, product analysis could not be performed, for this reason and due to the lack of evidence is unable to confirm the reported event.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.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of "clip failure to release from catheter" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "cause not established".
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip was used during a gastroscopy procedure on (b)(6) 2026 for polyp removal.During the procedure, the resolution 360 ultra clip would not release during attempted deployment.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 ; 9145716918
• MDR Report Key: 25017806
• Report Number: 3005099803-2026-01545
• Device Sequence Number: 9497396
• Product Code: PKL
• UDI-Device Identifier: 08714729997252
• UDI-Public: (01)08714729997252(17)290106(10)38288819
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: M00521401
• Device Catalogue Number: M00521401
• Device Lot Number: 0038288819
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 01/07/2026
• 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