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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; CLIP, HEMOSTATIC
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BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; CLIP, HEMOSTATIC Back to Search Results
Model Number M00522610
Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2024
Event Type  malfunction  
Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a15 captures the reportable event of clip stuck and could not be deployed.
 
Event Description
It was reported to boston scientific corporation that a resolution clip device was used in the stomach for closure during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2024.During the procedure, the clip was stuck.The clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.There was abnormally high resistance felt before the handle spool reached the end of the stroke.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Event Description
It was reported to boston scientific corporation that a resolution clip device was used in the stomach for closure during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2024.During the procedure, the clip was stuck.The clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.There was abnormally high resistance felt before the handle spool reached the end of the stroke.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a15 captures the reportable event of clip stuck and could not be deployed.Block h10: investigation results.The returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned without the clip assembly attached and with evidence of full deployment.Also, the device returned without the outer sheath, just with a portion buckled at the distal end of the catheter.Dimensional analysis was performed, and the measures were found to be within specification.No other problems with the device were noted.The reported event of clip stuck and could not be deployed was not confirmed.Investigation found that the device was returned without the clip assembly and with evidence of full deployment, indicating that the clip did release from the catheter.However, it is important to mention that the presence of the clip assembly is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.Additionally, it is important to take into 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 device components dimensions interfered with the device performance.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.
 
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Brand Name
RESOLUTION CLIP
Type of Device
CLIP, HEMOSTATIC
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 Key18711263
MDR Text Key336512621
Report Number3005099803-2024-00344
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729504795
UDI-Public08714729504795
Combination Product (y/n)N
Reporter Country CodeCH
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 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00522610
Device Catalogue Number2261
Device Lot Number0030763599
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age74 YR
Patient SexFemale
Patient Weight60 KG
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