MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	M00521242
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of the clip being unable to be released from the catheter.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the chronic non-atrophic (superficial) antral gastritis after hemostasis of multiple duodenal ulcer bleeding during an electronic gastroscopy procedure performed on (b)(6) 2025.During the procedure, the clip could not be deployed.The procedure was completed with another resolution 360 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 h2: (correction).Block b5 (describe event or problem) and block h6 (device code) have been corrected.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the chronic non-atrophic (superficial) antral gastritis after hemostasis of multiple duodenal ulcer bleeding during an electronic gastroscopy procedure performed on (b)(6) 2025.During the procedure, the clip could not be deployed.The procedure was completed with another resolution 360 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.Correction was identified on august 20,2025: it was reported that the clip was not able to grasp or lock onto tissue.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22282718
• Report Number: 3005099803-2025-02785
• Device Sequence Number: 8921925
• Product Code: PKL
• UDI-Device Identifier: 08714729875680
• UDI-Public: (01)08714729875680(17)261026(10)32737915
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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 Model Number: M00521242
• Device Catalogue Number: 54774
• Device Lot Number: 0032737915
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/22/2025
• Date Device Manufactured: 10/27/2023
• 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: 88 YR
• Patient Sex: Male
• Patient Weight: 58 KG