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

Model Number	M00521242
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code (b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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 submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, the clip was able to grasp and lock onto tissue, but failed to release from the catheter to deploy.The procedure was completed with another resolution 360 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
H6: medical device problem code a15 captures the reportable event of clip failed to release from catheter.H10: investigation results: the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the clip assembly was returned detached from the device and had evidence of a full deployment.It was observed that the clip arms were opened while one arm was bent.The clip wings were inside of the capsule windows, and this condition caused that the clip could not close its arms properly.Microscope examination was performed and it was found that the coil was unraveled.According to the evidence of coil unraveled, it happened likely due to the amount of the tissue grasped was bigger than the clip when attempting to close, causing the customer needed to apply an excess of force to close the clip arms, generating the coil was unraveled.No visible failures observed on the bushing hooks.Dimensional examination was performed on the bushing outer diameter, and it was noted to be within specification.A dimensional analysis was also performed between the hooks of the bushing, and both sides a and side b were within specification.No other issues with the device were noted.The reported event was not confirmed.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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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 submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, the clip was able to grasp and lock onto tissue, but failed to release from the catheter to deploy.The procedure was completed with another resolution 360 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.

• 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
• MDR Report Key: 12259565
• Report Number: 3005099803-2021-03897
• Device Sequence Number: 14350067
• Product Code: PKL
• UDI-Device Identifier: 08714729875680
• UDI-Public: 08714729875680
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: 03/18/2023
• Device Model Number: M00521242
• Device Catalogue Number: 54774
• Device Lot Number: 0025437767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 60