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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 M00521230
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem Discomfort (2330)
Event Date 05/03/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during a fibroscopy procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.It was reported that they had to tear the clip off the mucosa.The procedure was completed with a non bsc device.The patient felt significant discomfort.
 
Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of clip did not deploy.Imdrf patient code e2311 captures the reported event of discomfort.Imdrf impact code f11 captures the reported event of minor injury.
 
Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of clip did not deploy.Imdrf patient code e2311 captures the reported event of discomfort.Imdrf impact code f11 captures the reported event of minor injury.
 
Event Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during a fibroscopy procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.It was reported that they had to tear the clip off the mucosa.The procedure was completed with a non bsc device.The patient felt significant discomfort.Additional information received on may 26, 2023: it was reported that the name of procedure was esophagogastroduodenoscopy (egd).
 
Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of clip did not deploy.Imdrf patient code e2311 captures the reported event of discomfort.Imdrf impact code f11 captures the reported event of minor injury.Block h10: investigation results the returned resolution 360 clip device was analyzed, and a media analysis noted the device original label.It was also noted the evidence of full deployment and with the catheter kinked next to the bushing.A visual evaluation was performed, and the device returned without the clip assembly.Microscopic examination was performed, and it was found that the bushing had hits and the catheter was unraveled at the distal end.Dimensional analysis was performed between the hooks of the bushing and both sides were noted to be within specification.No other problems with the device were noted.The reported event of clip unable to release from the catheter was not confirmed.Investigation found that the device returned without the clip assembly and with evidence of full deployment.It is important to mention that the presence of this component is very important to the investigation, this because the event reported is directly related to this piece, and to get a clarification of which could be the reason of the problem faced by the physician, this component must be inspected.Additionally, it is important to take in consideration that during the product analysis, the dimensions between the hooks of the bushing were measured, and they were within specification.Excluding the possibility that the components dimensions interfered with the device performance.The analyzed condition of the catheter being unraveled was due to operational factors such as the user's technique during the clip deployment could have caused this failure.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 product labeling review identified that the device was not used per the instructions for use (ifu)/product label as the investigation found evidence of the device misuse at the information provided in the complaint.The ifu addresses correct steps for treat the device when this can't release normally form the catheter.The ifu states that, "do not forcibly pull back on a clip that is deployed and has not detached from the coil.This will tear the tissue and likely result in severe bleeding.A wire-cutter should be available on the endoscopy cart and be used to cut the coil where it exits the endoscope.The endoscope can then be removed leaving the clip and coil intact.The patient will require urgent surgery to remove the imbedded clip from the tissue.".
 
Event Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during a fibroscopy procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.It was reported that they had to tear the clip off the mucosa.The procedure was completed with a non bsc device.The patient felt significant discomfort.
 
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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 Key17011634
MDR Text Key316665067
Report Number3005099803-2023-02757
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729875628
UDI-Public08714729875628
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K222503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 07/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00521230
Device Catalogue Number54772
Device Lot Number0029973984
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2022
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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