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

Model Number	M00521402
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to the second of three resolution 360 ultra clips used during the same procedure.It was reported to boston scientific corporation that a resolution 360 ultra clip device was used during an unknown procedure performed on an unknown date, on an unknown anatomy.During the procedure, difficulty was observed in detaching the clip from the catheter.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated to (b)(6) 2026, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a15 captures the reportable event of clip difficult to detach from the catheter.Block h11: the device was not returned for analysis; therefore, a product analysis could not be performed.For this reason and due to the lack of evidence, it is unable to confirm the reported event.It was confirmed this device met manufacturing specifications 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 physician 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 meets all manufacturing specifications required and passed all the controls and inspections.No abnormalities were reported during the assembly process, and 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 a 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 lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25498608
• Report Number: 3005099803-2026-02442
• Device Sequence Number: 10589267
• Product Code: PKL
• UDI-Device Identifier: 08714729997269
• UDI-Public: (01)08714729997269(17)290210(10)38575837
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2026

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: M00521402
• Device Catalogue Number: M00521402
• Device Lot Number: 0038575837
• 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: 05/20/2026
• Initial Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 02/11/2026
• 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