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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT
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BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT Back to Search Results
Model Number M00521232
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem Tissue Damage (2104)
Event Date 02/17/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 360 clip was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip grasped and locked onto tissue, but failed to release from the catheter to deploy.Reportedly, when the clip was removed from the patient it pulled off some tissue, which increased the size of the polypectomy lesion.The procedure was completed with another resolution 360 clip device.The patient condition at the conclusion of the procedure was reported to be stable.
 
Event Description
It was reported to boston scientific corporation that a resolution 360 clip was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip grasped and locked onto tissue, but failed to release from the catheter to deploy.Reportedly, when the clip was removed from the patient it pulled off some tissue, which increased the size of the polypectomy lesion.The procedure was completed with another resolution 360 clip device.The patient condition at the conclusion of the procedure was reported to be stable.
 
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 360 clip device was analyzed, and a visual evaluation noted that the clip assembly was returned attached to the device.Microscope examination was performed on the clip assembly, and it was noted under high magnification that activations had been performed.It was also noted that the capsule locking tabs appeared damaged and the bushing had some marks in its hooks.Functional evaluation was performed using a tortuous path and the clip released from the catheter successfully.Dimensional examination was performed to further analyze the deployment issue; the handle was disassembled, and it was confirmed that the flattening wire was within specification.It was also noted that the control wire had some kinks.A dimensional examination was performed on the braided shaft, and it was within specification.No other issues with the device were noted.The reported event was 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 labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.
 
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Brand Name
RESOLUTION 360 CLIP
Type of Device
HEMOSTATIC METAL CLIP FOR THE GI TRACT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9829859
MDR Text Key191083723
Report Number3005099803-2020-00904
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729875642
UDI-Public08714729875642
Combination Product (y/n)N
PMA/PMN Number
K151802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/10/2022
Device Model NumberM00521232
Device Catalogue Number54774
Device Lot Number0024835007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2020
Date Manufacturer Received04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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