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

Model Number	M00521230
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip was used during an unknown procedure on (b)(6)2026 for treatment of irregular tissue of the digestive tract.During the procedure, when opening the packaging, it was noted that the resolution 360 clip had already been released inside of the packaging prior to any handling or any attempted deployment.There were no reported patient complications.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imrdf code a150103 captures the reportable event of premature deployment in an unknown location.Block h11: investigation results the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device, however response was not received.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 physician's technique during the procedure or was related to a device malfunction.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 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: 50354611
• Report Number: 3005099803-2026-03425
• Device Sequence Number: 6039647
• Product Code: PKL
• UDI-Device Identifier: 08714729875628
• UDI-Public: (01)08714729875628(17)281214(10)38183606
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: M00521230
• Device Catalogue Number: M00521230
• Device Lot Number: 0038183606
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 12/15/2025
• 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