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

Model Number	M00522600
Medical Device Problem Codes	Premature Activation (1484); 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	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used to treat wound hemostasis during a special treatment by enteroscopy procedure performed on (b)(6) 2026.During the procedure, the clip was locked, but it could not be deployed.The procedure was completed with another resolution clip device.A photo was submitted by the customer showing the device outside the patient, and it could be observed that the clip prematurely deployed.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 h6: imdrf device code a150103 captures the reportable event of clip premature deployment at an unknown anatomy location.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of clip could not be deployed.Block h11: correction: block b5 (describe event or problem) and block h6 (device codes).
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used to treat wound hemostasis during a special treatment by enteroscopy procedure performed on (b)(6) 2026.During the procedure, the clip was locked, but it could not be deployed.The procedure was completed with another resolution clip device.A photo was submitted by the customer showing the device outside the patient, and it could be observed that the clip was partially released.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.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used to treat wound hemostasis during a special treatment by enteroscopy procedure performed on (b)(6) 2026.During the procedure, the clip was locked, but it could not be deployed.The procedure was completed with another resolution clip device.A photo was submitted by the customer showing the device outside the patient, and it could be observed that the clip was partially released.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 observed that the clip was already loose upon opening the package.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem) has been updated based on the additional information received on march 9, 2026.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used to treat wound hemostasis during a special treatment by enteroscopy procedure performed on (b)(6) 2026.During the procedure, the clip was locked, but it could not be deployed.The procedure was completed with another resolution clip device.A photo was submitted by the customer showing the device outside the patient, and it could be observed that the clip was partially released.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 observed that the clip was already loose upon opening the package.
Additional Manufacturer Narrative
Block h11: investigation results the returned resolution clip device was analyzed, and during visual inspection, it was found that the device was returned with the clip assembly detached from the bushing but attached to the control wire and with evidence of soft deployment.Additionally, the outer sheath was not returned.Microscopic evaluation was performed, and it was noted that the first activation was not performed.Media analysis was performed, and the photo provided shows the device with evidence of 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 partial release was confirmed.Investigation found that the device was returned with the clip assembly detached from the bushing but attached to the control wire and with evidence of soft deployment.Also, there is a picture confirming the analyzed condition.Regarding the soft deployment, it may have been caused by the insertion of the device into the scope, the physician's technique, or any unrecorded impacts to the joint during preparation.The joint capsule bushing might have detached due to an external force impacting this joint.Based on the thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.

• 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: 24251399
• Report Number: 3005099803-2026-00437
• Device Sequence Number: 8346618
• Product Code: PKL
• UDI-Device Identifier: 08714729504764
• UDI-Public: (01)08714729504764(17)280111(10)35606217
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K250066
• 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,Followup
• Report Date (Section B): 05/11/2026

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: M00522600
• Device Catalogue Number: M00522600
• Device Lot Number: 0035606217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/04/2026; 03/09/2026; 04/17/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/04/2026; 04/01/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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