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

Model Number	M00522600
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: imdrf device code a15 captures the reportable event of clip could not be deployed.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used for closure in the stomach during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2025.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.It was noted that the clip could not be deployed after it was opened.The procedure was completed with another resolution clip device.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 Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Initial reporter address 1: (b)(6).Initial reporter address 2: (b)(6).Block h6: imdrf device code a15 captures the reportable event of clip could not be deployed.The returned resolution clip was analyzed through visual evaluation.It was observed that the clip assembly was detached from the bushing but attached to the control wire, evidence of soft deployment.However, the outer sheath was not returned.No other problems were identified with the device.The reported event of the clip unable to release from the catheter was not confirmed, as the there were no problems detected.It was noted that the device was returned without the outer sheath, and the circumstances leading to this damage were unknown.Therefore, the most probable root cause of this complaint is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used for closure in the stomach during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2025.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.It was noted that the clip could not be deployed after it was opened.The procedure was completed with another resolution clip device.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.The device was not returned.

• 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: 23221085
• Report Number: 3005099803-2025-05040
• Device Sequence Number: 9410034
• Product Code: PKL
• UDI-Device Identifier: 08714729504764
• UDI-Public: (01)08714729504764(17)260718(10)32049983
• 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
• Report Date (Section B): 11/26/2025

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 Expiration Date: 07/18/2026
• Device Model Number: M00522600
• Device Catalogue Number: M00522600
• Device Lot Number: 0032049983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 72 KG