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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 Problems Unraveled Material (1664); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2023
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 gastroscopy 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.Another attempt was made to deploy the clip but still unsuccessful.The procedure was completed with another resolution 360 clip.It was reported that the catheter was unraveled next to the bushing.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Imdrf device code a15 captures the reportable event of would not release from the catheter.
 
Event Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the stomach during a gastroscopy 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.Another attempt was made to deploy the clip but still unsuccessful.The procedure was completed with another resolution 360 clip.It was reported that the catheter was unraveled next to the bushing.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of would not release from the catheter.Block h10: investigation results: the returned resolution 360 clip was analyzed, and a visual evaluation noted that the device was returned with the catheter cut at the middle of it.Microscopic examination was performed, and it was found that the cut section has evidence of a mechanical cut.No other problems with the device were noted.The reported event of clip could not detach from catheter was not confirmed.Investigation found that the device returned without the clip assembly section and with the catheter cut and with evidence of a mechanical cut.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is cause not established.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/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
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 Key16577237
MDR Text Key312044326
Report Number3005099803-2023-01410
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729875642
UDI-Public08714729875642
Combination Product (y/n)N
Reporter Country CodeSP
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
Report Date 04/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number0030462215
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/27/2023
Initial Date FDA Received03/20/2023
Supplement Dates Manufacturer Received03/28/2023
Supplement Dates FDA Received04/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2022
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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