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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 Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2020
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 mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the cecum during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip grasped and locked onto tissue, but when the device was reopened, it did not go as usual and the clip was not release from the catheter to deploy.Reportedly, the physician held pressure to the clip and tissue without tearing the clip away or creating a perforation and with subtle manipulation of the scope, the clip released.The procedure was completed with another resolution 360 clip device.The patient was fully recovered.
 
Event Description
It was reported to boston scientific corporation that a resolution 360 clip device was used in the cecum during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the clip grasped and locked onto tissue, but when the device was reopened, it did not go as usual and the clip was not release from the catheter to deploy.Reportedly, the physician held pressure to the clip and tissue without tearing the clip away or creating a perforation and with subtle manipulation of the scope, the clip released.The procedure was completed with another resolution 360 clip device.The patient was fully recovered.
 
Manufacturer Narrative
Block h6: device code 2906 captures the reportable event of clip failed to release from the catheter.Block h10: investigation results the returned resolution 360 clip device was analyzed, and a visual evaluation noted that the clip assembly was returned detached from the device with evidence of a full deployment.It was also noted that the spool was separated without the control wire.Microscope examination was performed on the clip assembly, and it was confirmed that the clip wings were inside of the capsule windows, indicating that the activations had been performed.It was observed that the bushing had hits on its hooks and the one of the bushing tabs was rounded, indicating the clip may had been difficult to release from the catheter.The clip assembly was deformed at the proximal section.The clip was disassembled for further analysis, and no other visible failures were observed on its components.Dimensional examination was performed on the bushing outside diameter, and it was within specification.A dimensional examination was also performed between the hooks of the bushing, and both sides a and b were found to be out of specification, indicating the deployment failure.No other issues with the device were noted.The reported event was not confirmed.This failure is likely due to problems traced to manufacturing process.Therefore, the most probable root cause is manufacturing deficiency.An investigation is in place to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.Block h11: on (b)(6), 2020, additional information was received stating that the correct date boston scientific corporation became aware of this event was on (b)(6), 2020.
 
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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
MDR Report Key10871200
MDR Text Key226805307
Report Number3005099803-2020-05511
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729875642
UDI-Public08714729875642
Combination Product (y/n)N
PMA/PMN Number
K151802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/04/2021
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 Date11/01/2022
Device Model NumberM00521232
Device Catalogue Number54774
Device Lot Number0024781752
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Initial Date Manufacturer Received 10/26/2020
Initial Date FDA Received11/19/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received01/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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