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

Model Number	M00522610
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of clip unable to deploy.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip was used in the stomach fundus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2026.During the procedure, the clip could not be deployed completely.The procedure was completed with another resolution clip.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 stable.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h2 (additional information): block b5 (describe event or problem) and block h6 (device code) have been updated based on the additional information received on february 12, 2026.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip was used in the stomach fundus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2026.During the procedure, the clip could not be deployed completely.The procedure was completed with another resolution clip.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 stable.Additional information received on february 12, 2025.It was clarified that the main problem of the device was the clip unable to grasp onto tissue, thus making this a poor bite issue not a deployment issue.

• 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: 24314906
• Report Number: 3005099803-2026-00560
• Device Sequence Number: 4837693
• Product Code: PKL
• UDI-Device Identifier: 08714729504795
• UDI-Public: (01)08714729504795(17)270604(10)34165714
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

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: 0034165714
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 02/12/2026; 04/23/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/03/2026; 05/12/2026
• Date Device Manufactured: 06/04/2024
• 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 Age: 40 YR
• Patient Sex: Male
• Patient Weight: 60 KG