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

Model Number M00522612

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip was tried to open, but it did not open correctly.The clip finally opened and it was able to grasp and lock onto tissue, however, the clip did not separate from the catheter to deploy.Reportedly, the pop stage of deployment was not heard, and the control wire in the handle was broken so no resistance was felt.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the clip was tried to open, but it did not open correctly.The clip finally opened and it was able to grasp and lock onto tissue; however, the clip did not separate from the catheter to deploy.Reportedly, the pop stage of deployment was not heard and the control wire in the handle was broken so no resistance was felt.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device code 2906 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 with the clip got stuck inside of the bushing.It was also confirmed that the handle felt disconnected from the most distal section and the catheter was kinked at the most proximal section, indicating excessive manipulation on the device.Microscope examination was performed, and it was found that no activations had been performed.The capsule was deformed at the proximal section and the bushing had a hit in one of its hooks.The clip assembly was disassembled for further analysis, and no failures were observed on its components.Dimensional examination was performed on the bushing outside diameter, and it was confirmed to be out of specification.Additionally, x-ray analysis was performed, and it was possible to observe that the yoke was detached from the control wire, confirming that it is not possible to take control of the clip assembly to open its arms and perform the deployment.No other issues 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 device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A review of the instructions for use (ifu) and product labeling was completed and did not reveal any evidence of device misuse or that the device was used in a manner inconsistent with the labeled indications.

• Brand Name: RESOLUTION CLIP CLIPPING DEVICE
• Type of Device: CLIP, HEMOSTATIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10884388
• MDR Text Key: 217723309
• Report Number: 3005099803-2020-05674
• Device Sequence Number: 1
• Product Code: MCH
• UDI-Device Identifier: 08714729504818
• UDI-Public: 08714729504818
• Combination Product (y/n): N
• PMA/PMN Number: K040148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2023
• Device Model Number: M00522612
• Device Catalogue Number: 2261
• Device Lot Number: 0025208456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1