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	06/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imrdf code a15 captures the reportable event of clip difficult to release from catheter.Block h11: investigation results: the resolution 360 ultra clip was implanted and not returned for analysis; therefore, a technical analysis could not be performed.Product analysis could not be carried out, for this reason and due to the lack of evidence is unable to confirm the reported event.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.Based on the event description and information provided by the customer there is not enough evidence to determine whether the issue was induced due to the physicians technique during the procedure or was related to a device malfunction.Additionally, 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 definitive cause of the reported issue cannot be established due to lack of evidence.Without proper evaluation of the device, it remains unknown the causes that contributed to the event.Based on the 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 ultra clip was used in the colon during a colonoscopy procedure for polyps performed on (b)(6) 2026.During the procedure, the clip was unable to detach from the catheter.Eventually, the catheter was pulled back and the clip detached.The procedure was completed with the original 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.

• 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: 25673416
• Report Number: 3005099803-2026-02624
• Device Sequence Number: 10407251
• Product Code: PKL
• UDI-Device Identifier: 08714729997252
• UDI-Public: (01)08714729997252(17)290315(10)38848949
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• 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: M00521401
• Device Catalogue Number: M00521401
• Device Lot Number: 0038848949
• 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: 06/08/2026
• Initial Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 03/16/2026
• 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