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

Model Number	M00521240
Medical Device Problem Codes	Use of Device Problem (1670); 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	02/22/2024
Type of Reportable Event	Malfunction
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 during an endoscopy of upper gastrointestinal 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, the clip remained attached to the catheter.Due to the clip's incapacity to control the bleeding, there was some blood loss.However, this was controlled by completing the procedure using another resolution 360 clip.There were no patient complications reported as a result of this event.Note: it was reported that the scope used was a duodenoscope.However, per the instructions for use, hemostasis clip is designed to be compatible with forward viewing endoscopes only.
Additional Manufacturer Narrative
Block h6: imdr device code a15 captures the reportable event of clip would not detach 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 during an endoscopy of upper gastrointestinal 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, the clip remained attached to the catheter.Due to the clip's incapacity to control the bleeding, there was some blood loss.However, this was controlled by completing the procedure using another resolution 360 clip.There were no patient complications reported as a result of this event.Note: it was reported that the scope used was a duodenoscope.However, per the instructions for use, hemostasis clip is designed to be compatible with forward viewing endoscopes only.
Additional Manufacturer Narrative
Block h6: imdr device code a15 captures the reportable event of clip would not detach 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 detached from the bushing but attached to the control wire and with evidence of soft deployment.Microscopic inspection was performed and it was noted that a first activation was not performed.No other problems with the device were noted.The reported event of clip would not detrach from the catheter was not confirmed.It was found that the device was returned with evidence of soft deployment and without any activations.This means that the capsule became detached from the bushing, losing its functionality to open and close properly.The soft deployment may have been caused by any unrecorded impacts to the joint during preparation, by the insertion of the device into the scope, or the physician's technique.The joint capsule bushing might have detached due to an external force impacting this joint.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure.

• 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: 18890369
• Report Number: 3005099803-2024-01033
• Device Sequence Number: 18043767
• 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
• Device Implanted Year: 2024
• 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): 09/10/2025

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: 02/22/2024
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 09/10/2025
• 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: 50 YR
• Patient Sex: Male