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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip device was used for a polyp in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2026.During the procedure, the clip was able to grasp and lock onto tissue but was unable to deploy from the catheter initially.The physician unlocked the tissue and attempted to release the clip again.The clip eventually released from the catheter.The procedure was completed with the original 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).Block h6: imdrf device code a15 captures the reportable event of clip difficult to release from catheter.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h2: additional information: block b5 (describe event or problem) has been updated based on the additional information received on march 9, 2026.Block h6: imdrf device code a15 captures the reportable event of clip failure to release from catheter.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip device was used for a polyp in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2026.During the procedure, the clip was able to grasp and lock onto tissue but was unable to deploy from the catheter initially.The physician unlocked the tissue and attempted to release the clip again.The clip eventually released from the catheter.The procedure was completed with the original 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 information received on march 9, 2026: it was noted that it came off tissue; however, the clip was still attached to the catheter.Upon removing the clip through the scope, the clip finally released.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a15 captures the reportable event of clip failure to release from catheter.Block h11: investigation results the returned resolution 360 clip device was analyzed, and during visual inspection, it was found that the device was returned without the clip assembly.The device was able to perform a full deployment with no problems.During media inspection, a photo shows evidence of the device with soft deployment.No other problems with the device were noted.It was confirmed this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations which could have contributed to the reported event.The reported event of clip failure to release from was not confirmed.The investigation results did not detect any problems related to the reported issue, as there is no evidence that complications occurred, as the device was returned fully deployed.Therefore, the most probable root cause for this complaint is no problem detected.Block h11: block d4 (model number) has been corrected.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip device was used for a polyp in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2026.During the procedure, the clip was able to grasp and lock onto tissue but was unable to deploy from the catheter initially.The physician unlocked the tissue and attempted to release the clip again.The clip eventually released from the catheter.The procedure was completed with the original 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 information received on march 9, 2026 it was noted that it came off tissue; however, the clip was still attached to the catheter.Upon removing the clip through the scope, the clip finally released.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24512107
• Report Number: 3005099803-2026-00822
• Device Sequence Number: 15942597
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

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: 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 04/17/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/06/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 71 KG