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

Model Number	M00521401
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 ultra clip was used in the upper gastrointestinal tract during an esophagogastroduodenoscopy (egd) procedure performed on an unknown date.During the procedure, when the clip was passed down to the working channel, it was found that the clip had already fired inside the outersheath.The procedure was completed with another resolution 360 ultra device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated to december 1, 2023 based on the date the manufacturer became aware of the event.Block h6: imdrf device code a150103 captures the reportable event of clip premature deployment during an egd in the upper gastrointestinal tract.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 ultra clip was used in the upper gastrointestinal tract during an esophagogastroduodenoscopy (egd) procedure performed on an unknown date.During the procedure, when the clip was passed down to the working channel, it was found that the clip had already fired inside the outersheath.The procedure was completed with another resolution 360 ultra device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated to december 1, 2023 based on the date the manufacturer became aware of the event.Block h6: imdrf device code a150103 captures the reportable event of clip premature deployment during an egd in the upper gastrointestinal tract.Block h10: investigation results: the returned resolution 360 ultra 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, evidence of soft deployment.Microscopic examination was performed, and it was found that the capsule bottom part was damaged, and the first activation was not performed.No other problems with the device were noted.The reported event of clip premature deployment was confirmed.During product analysis it was found that the clip had evidence of soft deployment since the clip was detached from the bushing but still attached to the control wire.Also, after a microscope analysis, it was found that the capsule had both sides damaged and lifted, consequently, the root cause of the clip assembly detachment.Most likely during unpacking of the device, the clip was hit against a hard surface, causing the damage on the capsule, this possible hit, lifted the locking tab, which function is to attach the clip to the bushing, therefore, with this component lifted, there is not enough subjection between the clip and the bushing, causing the reported problem on the device.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.

• Brand Name: RESOLUTION 360 ULTRA 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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18557809
• Report Number: 3005099803-2024-00075
• Device Sequence Number: 11594804
• Product Code: PKL
• UDI-Device Identifier: 08714729997252
• UDI-Public: 08714729997252
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: M00521401
• Device Catalogue Number: 2140
• Device Lot Number: 0032278283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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