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

Model Number	M00521231
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip was used during a procedure.During the procedure, when the clip was deployed it failed to release from the catheter.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the procedure details to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imrdf device code a15 captures the reportable event of clip failure to release from catheter.Block b3: approximated based on the date the manufacturer became aware of the event.Block h11: investigation results the resolution 360 clip was not returned for analysis; therefore, a technical analysis could not be performed, and 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.A similar complaint review was completed.There were no emerging trends identified that warrant further action.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.

• 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: 50803378
• Report Number: 3005099803-2026-03830
• Device Sequence Number: 8543015
• Product Code: PKL
• UDI-Device Identifier: 08714729875635
• UDI-Public: (01)08714729875635(17)290515(10)39352684
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: M00521231
• Device Catalogue Number: M00521231
• Device Lot Number: 0039352684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 05/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown