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

Model Number	M00521240
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of clip did not release from the catheter.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the duodenum for gastrointestinal bleeding (gi) bl during an upper gastrointestinal endoscopy procedure performed on (b)(6), 2024.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.Instead of the clip deploying at the bleeder spot, it remained intact to the catheter causing inability to stop the bleeding.It was reported that abnormally high resistance was felt before the handle spool reached the end of the stroke.The procedure was completed with another resolution 360 clip device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of clip did not release from the catheter.Block h11: investigation results the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly stuck into the bushing without the first activation performed and the handle does not have any restriction.Microscopic inspection was performed and it was observed that the clip assembly bottom part is deformed.No other problems with the device were noted.The reported event of clip unable to release from catheter was not confirmed.It was found that the clip assembly was returned without the first activation performed.Additionally, it was noted that the clip had evidence of soft deployment, as the clip was detached from the bushing but still attached to the control wire.It is possible that 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.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, consequently deforming the capsule.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the duodenum for gastrointestinal bleeding (gi) during an upper gastrointestinal endoscopy procedure performed on (b)(6) 2024.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.Instead of the clip deploying at the bleeder spot, it remained intact to the catheter causing inability to stop the bleeding.It was reported that abnormally high resistance was felt before the handle spool reached the end of the stroke.The procedure was completed with another resolution 360 clip device.There were no patient complications reported as a result of this event.

• 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; propark, coyol; alajuela ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 19310839
• Report Number: 3005099803-2024-02109
• Device Sequence Number: 11535191
• Product Code: PKL
• UDI-Device Identifier: 08714729875666
• UDI-Public: 08714729875666
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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 Expiration Date: 05/15/2025
• Device Model Number: M00521240
• Device Catalogue Number: 54772
• Device Lot Number: 0029505510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 61 KG