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

Model Number	M00521400
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imrdf code a150201 captures the reportable event of clip falls into the patient in an open state during egd or unknown procedure, also unknown location or esophagus.Block h11: investigation results the resolution 360 clip ultra was not returned for analysis; therefore, a technical analysis could not be performed, for this reason and due to the lack of evidence is unable to confirm the reported event.A review of the device history record (dhr) was performed.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.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.Additionally, based on the most relevant information for the complaint including product record review results, the device met all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.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.The procedure was completed with a resolution 360 clip.Therefore, the code of additional device required will be classified as adverse event related to procedure since the adverse event occurred due to the issues encountered during procedure.Based on the thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 ultra clip was used during a large polyp removal procedure performed on (b)(6) 2026.During the procedure, the clip deployed in the open position.The anatomy location is unknown.The procedure was completed with a resolution 360 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 fully recovered.Note: this report pertains to the first of three devices used during the same procedure.

• Brand Name: RESOLUTION 360? ULTRA 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 ; 9145716918
• MDR Report Key: 25522810
• Report Number: 3005099803-2026-02478
• Device Sequence Number: 10571904
• Product Code: PKL
• UDI-Device Identifier: 08714729997245
• UDI-Public: (01)08714729997245(17)290309(10)38805005
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: M00521400
• Device Catalogue Number: M00521400
• Device Lot Number: 0038805005
• 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: 05/22/2026
• Initial Report FDA Received Date: 06/16/2026
• Date Device Manufactured: 03/10/2026
• 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