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

Model Number	M00522600
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a15 captures the reportable event of clip failed to release from the catheter.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in the esophagus during a endoscopic submucosal dissection (esd) performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock the tissue; however, the clip could not be deployed.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient 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 in the esophagus during a endoscopic submucosal dissection (esd) performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock the tissue; however, the clip could not be deployed.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of clip failed to release from the catheter.Block h10: investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly and the device had evidence of premature deployment.The device was returned without the over-sheath.Microscopic examination was performed, and it was found that the bushing had hit marks.The yoke was returned attached to the control wire.Dimensional analysis was also performed between the hooks of the bushing and both sides were noted to be within specification.No other problems with the device were noted.The reported event of clip could not be deployed was not confirmed.Investigation found that the bushing had hit marks, this is likely due to the interaction between the yoke and the capsule, in order to deploy the clip.Regarding the yoke was returned attached to the control wire, this could be due to operational factors during the procedure such as trying to open the clip once it was already activated.The device was returned without the clip assembly and 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 dimensions interfered with the device performance.Therefore, the most probable root cause for this complaint is no problem detected.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16573964
• Report Number: 3005099803-2023-01451
• Device Sequence Number: 7170544
• Product Code: PKL
• UDI-Device Identifier: 08714729504764
• UDI-Public: 08714729504764
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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: 05/24/2024
• Device Model Number: M00522600
• Device Catalogue Number: 2260
• Device Lot Number: 0027465380
• 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: 03/02/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 65 KG