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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP CLIPPING DEVICE; CLIP, HEMOSTATIC
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BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP CLIPPING DEVICE; CLIP, HEMOSTATIC Back to Search Results
Model Number M00522611
Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 gastrointestinal (gi) during gastric endoscopy procedure performed on (b)(6) 2021.During the procedure, the clip was attempted to be deployed, but would not separate from the catheter and remained open.The device was removed, and it was noted that the clip was able to close outside the patient.The procedure was completed with a different 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
Block h6: medical device problem code a15 captures the reportable event of clip failed to release from catheter.Block h10: investigation results the returned resolution clip device was analyzed, and a visual evaluation noted that the clip assembly was not returned.The catheter was kinked near to the handle and the device returned with the outer sheath.Microscope examination was performed, and it was noted that the device had evidence of a full deployment.Dimensional analysis was performed on the outside diameter of the bushing, and it was noted to be within specification.A dimensional analysis was also performed between the hooks of the bushing, and both sides a and b were within specification.Further analysis was done to measure the bushing tabs and both sides had similar measurement.No other issues with the device were noted.The reported event was not confirmed.The device returned without the clip assembly and it is important to mention that the presence of this component is very important to the investigation in order to analyze any failure that could contribute with the problem faced by the physician.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.
 
Event Description
It was reported to boston scientific corporation that a resolution clip device was used in gastrointestinal (gi) during gastric endoscopy procedure performed on (b)(6) 2021.During the procedure, the clip was attempted to be deployed, but would not separate from the catheter and remained open.The device was removed, and it was noted that the clip was able to close outside the patient.The procedure was completed with a different 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.Additional information received on august 04, 2021: it was reported that during attempted deployment, there was a crackle in the stages of deployment, but after that nothing else happened and the clip was unable to release from the catheter to deploy.Additional information received on august 27, 2021: note: the customer provided a photo showing a clip remained open.
 
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Brand Name
RESOLUTION CLIP CLIPPING DEVICE
Type of Device
CLIP, HEMOSTATIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12259183
MDR Text Key264498020
Report Number3005099803-2021-03896
Device Sequence Number1
Product Code MCH
UDI-Device Identifier08714729504801
UDI-Public08714729504801
Combination Product (y/n)N
PMA/PMN Number
K040148
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/27/2024
Device Model NumberM00522611
Device Catalogue Number2261
Device Lot Number0026793708
Was Device Available for Evaluation? No
Date Manufacturer Received08/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age76 YR
Patient Weight90
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