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

Model Number	M00522612
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of clip premature deployment at an unknown anatomy location.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip was used in an unknown anatomy during an egd (esophagogastroduodenoscopy) procedure performed on (b)(6) 2026.It was reported that the clip would deploy before deployment steps were taken.The procedure was completed with alternative method.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2 (correction): b5 (describe event or problem) has been updated for the correction of numbering of the devices.Block h6: imdrf device code a150103 captures the reportable event of clip premature deployment at an unknown anatomy location.Block h11: the resolution clip was not returned; therefore, product analysis could not be carried out, for this reason and due to the lack of evidence is unable to confirm the reported event.Based on the available information, the most probable cause of the reported issue cannot be determined due to insufficient evidence.The product was not returned for analysis to assess any potential device defects.Without a proper evaluation, it is not possible to identify the most likely factors that may have contributed to the event.Based on all available information, the probable root cause assigned is unable to exclude device problem.
Event or Problem Description
Note: this report pertains to the first of five resolution clip used during the same procedure.It was reported to boston scientific corporation that a resolution clip was used in an unknown anatomy during an egd (esophagogastroduodenoscopy) procedure performed on (b)(6) 2026.It was reported that the clip would deploy before deployment steps were taken.The procedure was completed with alternative method.There were no patient complications reported as a result of this event.

• Brand Name: RESOLUTION CLIP CLIPPING DEVICE
• 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: 24500187
• Report Number: 3005099803-2026-00805
• Device Sequence Number: 15920187
• Product Code: PKL
• UDI-Device Identifier: 08714729504818
• UDI-Public: (01)08714729504818(17)281208(10)38145963
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K222503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: M00522612
• Device Catalogue Number: 2261
• Device Lot Number: 0038145963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/26/2026
• Date Device Manufactured: 12/09/2025
• 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