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

Model Number	M00521401
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	06/28/2026
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 of gastrointestinal bleed.During the procedure, the clip was able to grasp and lock onto the tissue but failed to release from the catheter.There was no kinks noticed in the catheter.They tried to open of the handle, and it would not release.The procedure was completed with another of the same device.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 fully recovered.Additional information received: no tissue damage was generated since the clip did not deploy to the tissue.This report pertained to one of two devices used during the same procedure.
Additional Manufacturer Narrative
Block h6: imrdf code a15 captures the reportable event of clip failure to release from catheter.Block h11: investigation results the resolution 360 clip device was not returned for analysis.During the media inspection of the picture provided by the customer, it was observed that the clip assembly was attached and that the activations were performed.Additionally, the welding ball was not observed on the control wire.The reported event of clip failure to release from catheter was able to be confirmed.A review of the device history record (dhr) was performed.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.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on the most relevant information for the complaint including product record review results, the device met all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.The welding ball was not observed on the control wire, confirming the reported condition.However, the tabs could not be evaluated based on the available media, as they were not visible.Based on the thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 25876964
• Report Number: 3005099803-2026-02947
• Device Sequence Number: 10642731
• Product Code: PKL
• UDI-Device Identifier: 08714729997252
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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: 0038632934
• Was Device Available for Evaluation?: No
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 07/13/2026; 08/28/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/06/2026; 09/22/2026
• Date Device Manufactured: 02/18/2026
• 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