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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 02/15/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a resolution clip device was used in the intestine during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure, the physician pushed the handle; however, the clip could not be detached from the catheter to deploy.The clip eventually fell off after pulling 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 condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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.
 
Manufacturer Narrative
Block h6: medical device problem code a15 captures the reportable event of clip unable to release from catheter.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 and the device had evidence of a full deployment.The device was returned without its outer-sheath.It was also observed that the bushing had evidence of flaring.Microscopic examination was performed and it was found that the bushing had hit marks and the bushing tabs were rounded.Dimensional analysis was performed on the bushing outer diameter, and it was found to be within specification.A dimensional analysis was also performed between the hooks of the bushing and the pin gage, and both were confirmed to be out of specification.No other problems with the device were noted.Based on the condition of the returned device, the reported event of clip unable to release from catheter was confirmed.Investigation found that the hooks of the bushing were out of specification and the capsule tabs were rounded with evidence of flaring of the capsule into the bushing which can be traced to the manufacturing process as a contributing factor and may have contributed to the clip deployment problem.Additionally, the hit marks found on the bushing is likely due to the flaring of the capsule onto the bushing.Therefore, the most probable root cause is manufacturing deficiency, as the reported event was traced to the manufacturing process.An investigation to address this problem is in progress.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
Event Description
It was reported to boston scientific corporation that a resolution clip device was used in the intestine during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure, the physician pushed the handle; however, the clip could not be detached from the catheter to deploy.The clip eventually fell off after pulling 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 condition at the conclusion of the procedure was reported to be stable.
 
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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 Key13769856
MDR Text Key287262646
Report Number3005099803-2022-01394
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
Reporter Occupation Physician
Type of Report Followup
Report Date 04/13/2022
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 Model NumberM00522610
Device Catalogue Number2261
Device Lot Number0027814651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/15/2022
Supplement Dates Manufacturer Received03/16/2022
Supplement Dates FDA Received04/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age58 YR
Patient SexFemale
Patient Weight55 KG
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