MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; CLIP, HEMOSTATIC

Model Number	M00522610
Medical Device Problem Codes	Premature Activation (1484); Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter first name: (b)(6).Block h6: imdrf device code a150103 captures the reportable event of clip premature deployment during an unknown procedure at an unknown anatomy location.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used during an unknown procedure performed on (b)(6) 2025.The anatomical location is unknown.During the procedure, the clip would not open.It was noted that the clip prematurely deployed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used during an unknown procedure performed on (b)(6) 2025.The anatomical location is unknown.During the procedure, the clip would not open.It was noted that the clip prematurely deployed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block e1: initial reporter first name: (b)(6).Block h11: block h6 has been amended to reflect a correction identified during review on january 15, 2026.Imdrf device code a15 (clip partial release) at an unknown anatomy location is nonreportable.Following this correction, the manufacturer has determined that the event does not meet the reporting criteria for the device in question.

• Brand Name: RESOLUTION CLIP
• Common Device Name: CLIP, HEMOSTATIC
• 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: 24068106
• Report Number: 3005099803-2026-00202
• Device Sequence Number: 18420386
• Product Code: PKL
• UDI-Device Identifier: 08714729504795
• UDI-Public: (01)08714729504795(17)261215(10)33071564
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: M00522610
• Device Catalogue Number: M00522610
• Device Lot Number: 0033071564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 12/16/2023
• 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