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	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a resolution clip device was used in stomach during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, the clip could not detach after advancing from the forceps channel of the scope.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's 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 stomach during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, the clip could not detach after advancing from the forceps channel of the scope.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***correction*** the correct procedure date is (b)(6), 2021.***additional information received on (b)(6), 2022*** it was reported that the clip was able to grasp and lock onto tissue; however, it could not be deployed from the catheter to deploy.
Additional Manufacturer Narrative
Block h2 (additional information): updated block b5 (describe event or problem) block h6: medical device problem code a15 captures the reportable event of clip failed to release from catheter.Block h10: investigation results the returned resolution clip was analyzed, and a visual evaluation noted that that clip assembly was stuck into the bushing and the outer sheath was not returned with the device.It was observed that the catheter was cut and the handle was not returned.Microscope examination was performed, and it was found that the clip assembly had been activated.The bushing had hits and friction marks.Dimensional examination was performed, on the bushing outer diameter, and it noted to be within specification.A dimensional analysis was performed between the hooks of the bushing, and it was observed that both sides a and b were within specification.It was noted that the bushing tabs measurement was symmetrical.No other problems with the device were noted.The reported event was confirmed.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11 (correction): block b5 (event date), e1 (initial reporter email).

• 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 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: 13254188
• Report Number: 3005099803-2022-00092
• Device Sequence Number: 4428517
• Product Code: MCH
• UDI-Device Identifier: 08714729504764
• UDI-Public: 08714729504764
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040148
• 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): 02/11/2022

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: 0027465381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/11/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 71 KG