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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that two resolution 360 clip devices were used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, both clips grasped and locked onto tissue, but did not release from the catheter to deploy.In the stages of deployment, snap and crackle were felt but there was no pop.The same issue happened with the second resolution 360 clip device.The procedure was completed with another resolution 360 clip device.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that two resolution 360 clip devices were used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, both clips grasped and locked onto tissue, but did not release from the catheter to deploy.In the stages of deployment, snap and crackle were felt but there was no pop.The same issue happened with the second resolution 360 clip device.The procedure was completed with another resolution 360 clip device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: medical device problem code a15 captures the reportable event of clip was unable to release from catheter.Block h10: investigation results: the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the clip assembly was not returned and the device had evidence of a full deployment.Microscope examination was performed, and it was observed that the bushing had hit marks on the bushing surface, indicating the interaction between the yoke and the capsule in order to make the deployment of the clip.Dimensional analysis was performed on the bushing outer diameter, and it was within specification.A dimensional analysis was performed between the hooks of the bushing, and both sides a and b were within specification.The bushing tabs measurement were symmetric and the flattening wire was confirmed to be within specification.Further dimensional analysis was performed on the braided shaft, and the lengths of various parts were within specification.No other problems with the device were noted.The reported event was not confirmed.The device returned without the clip assembly and it is important to mention that the presence of this component is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.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 device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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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
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 Key13110555
MDR Text Key286270054
Report Number3005099803-2021-08019
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729875642
UDI-Public08714729875642
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00521232
Device Catalogue Number54774
Device Lot Number0027187755
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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