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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 Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a resolution clip device was used in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure, the handle was pushed; however, the clip could not detach from the catheter to deploy.The clip eventually fell off inside the patient after pulling the handle back and forth.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
(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 a resolution clip device was used in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure, the handle was pushed; however, the clip could not detach from the catheter to deploy.The clip eventually fell off inside the patient after pulling the handle back and forth.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
Medical device problem code a15 captures the reportable event of clip could not detach from the catheter.Block h10: investigation results the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly attached.The device was returned without the over-sheath and the catheter was kinked near the clip assembly.Additionally, the coil was unraveled next to the bushing.Microscopic examination was performed and it was found that the clip assembly had no activation since the clip arms can be opened.Functional evaluation was performed and the clip assembly was able to perform the first activation and could be released from the catheter without problem.No problems with the device were noted.The reported event of clip unable to release from the catheter was not confirmed.Investigation found that the catheter was kinked and the coil was unraveled next to the bushing, this is likely due to operational factors such as the insertion or removal of the device through the scope, and the sheath removal.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 manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
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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 Key14207912
MDR Text Key290070373
Report Number3005099803-2022-02101
Device Sequence Number1
Product Code MCH
UDI-Device Identifier08714729504795
UDI-Public08714729504795
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K040148
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/25/2022
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 Expiration Date08/11/2022
Device Model NumberM00522610
Device Catalogue Number2261
Device Lot Number0024337618
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2022
Initial Date FDA Received04/26/2022
Supplement Dates Manufacturer Received06/30/2022
Supplement Dates FDA Received07/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2019
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 Age48 YR
Patient SexFemale
Patient Weight50 KG
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