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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
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 stomach during an endoscopic 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.The device was removed.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
H6: imdrf device code a15 captures the reportable event of clip did not release properly.
Event or Problem Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during an endoscopic 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.The device was removed.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 properly.Block h10: investigation results the returned resolution 360 clip device was analyzed, and it was found that the clip assembly was not returned and with evidence of premature deployment.Additionally, the customer provided a picture where it was possible to observe the device with evidence of premature deployment.Dimensional analysis was performed, and the measures were found to be within specification.No other problems with the device were noted.The reported event of clip did not release properly was not confirmed.Investigation found that the device was returned without the clip assembly and with evidence of premature deployment.Evidence that the clip, did release from the catheter.It is important to mention that the presence of this component is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.Additionally, it is important to take in consideration that during the product analysis, the dimensions between the hooks of the bushing were measured, and they were within specification, excluding the possibility that the device components interaction were the root cause of the reported allegation.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.

• 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 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: 18753817
• Report Number: 3005099803-2024-00502
• Device Sequence Number: 3729740
• Product Code: PKL
• UDI-Device Identifier: 08714729875666
• UDI-Public: 08714729875666
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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 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: 01/25/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/25/2024
• 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: 61 YR
• Patient Sex: Female