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

Model Number	M00522610
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	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic submucosal dissection (esd) procedure for bleeding, performed on (b)(6) 2025.During the procedure, the clamp head of the handle could not be released after being pushed and pulled multiple times.The procedure was completed using 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.No further information has been obtained despite good-faith efforts.
Additional Manufacturer Narrative
Block a2: date of birth: it was reported that the date of birth was (b)(6) 1967.Block h6: imdrf device code a15 captures the reportable event of the clip being unable to be released from the catheter.
Additional Manufacturer Narrative
Block a2: date of birth: it was reported that the date of birth was (b)(6) 1967.Block h6: imdrf device code a15 captures the reportable event of the clip being unable to be released from the catheter.Block h11: the returned resolution clip was analyzed, and a visual evaluation noted that the device returned with the clip assembly stuck into the bushing, and the outer sheath did not return.Microscopic inspection was performed; however, no activations were performed.No other problems with the device were noted.The reported events of clip unable to release from catheter was confirmed.Upon analysis, tit was found that the clip had evidence of soft deployment, as the clip was detached from the bushing but still attached to the control wire.This might occur due to operational factors during the procedure, such as the physician's technique during the deployment of the clip, the scope position/angle, or detachment of the capsule due to hitting a surface.However, these are only hypotheses.After the soft deployment occurs, it could happen that upon reopening the clip, the capsule gets detached, and when the physician tries to close it again, a misalignment of the capsule bushing can cause it to get stuck into the bushing during retraction.With all available information, the most probable root cause of this complaint is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic submucosal dissection (esd) procedure for bleeding, performed on (b)(6) 2025.During the procedure, the clamp head of the handle could not be released after being pushed and pulled multiple times.The procedure was completed using 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.

• 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: 23817650
• Report Number: 3005099803-2025-06730
• Device Sequence Number: 13114074
• Product Code: PKL
• UDI-Device Identifier: 08714729504795
• UDI-Public: (01)08714729504795(17)270423(10)33888744
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 0033888744
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 55 KG