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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP CLIPPING DEVICE; CLIP, HEMOSTATIC
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BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP CLIPPING DEVICE; CLIP, HEMOSTATIC Back to Search Results
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
Device captures the reportable event of clip failed to release from the catheter.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 clip assembly was not returned with the device.The device was returned without the over-sheath.It was also observed that the device was returned completely disassembled with the catheter was cut from the handle.The control wire was returned outside of the catheter, was kinked and the spool was separated from the handle.The catheter was kinked and unraveled at the most distal section.Microscope examination was performed; the bushing had hits on its hooks, and one of the bushing tabs was rounded, indicating that the observed failures could be evidence of difficulty experienced when attempting to release the clip from the catheter.Dimensional examination was performed to further analyze the deployment issue, and the bushing outside diameter was confirmed to be within specification.A dimensional analysis was also performed between the hooks of the bushing, and both sides a and side b were found to be ouf of specification.No other issues with the device were noted.The reported event was not confirmed.This failure is likely due to problems traced to manufacturing process.Therefore, the most probable root cause is manufacturing deficiency.An investigation is in place to address this issue.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.
 
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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 Key10884335
MDR Text Key217659987
Report Number3005099803-2020-05675
Device Sequence Number1
Product Code MCH
UDI-Device Identifier08714729504818
UDI-Public08714729504818
Combination Product (y/n)N
PMA/PMN Number
K040148
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Model NumberM00522612
Device Catalogue Number2261
Device Lot Number0025055328
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
Date Manufacturer Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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