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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 ULTRA CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT
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BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 ULTRA CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT Back to Search Results
Model Number M00521401
Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event was approximated to (b)(6) 2020, as the event date is unknown.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 two resolution 360 ultra clip devices were used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the clip grasped onto tissue, but the clip did not come out to deploy.Reportedly, it was noted that there was no click sound.It was also observed that the packaging was damaged.The same issue occurred with the second resolution 360 ultra clip.The procedure was completed with another resolution 360 ultra clip device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Block b3: date of event was approximated to 10/01/2020 as the event date is unknown.Block h6: conclusion code 67 is being used to capture that the event is no longer reportable.Block h10: investigation results the returned resolution 360 ultra clip device was analyzed, and a visual evaluation noted that the clip assembly was returned attached to the device; however, the clip arm looked bent.Microscope examination was performed, and it was confirmed that activations had not been performed.Functional evaluation was performed using a tortuous fixture, the clip was able to open and close, and the clip released from the catheter successfully.Additionally, x-ray analysis was performed on the device, and no discernible defect could be seen.No other issues with the device were noted.A review of the instructions for use (ifu) and product labeling was completed and did not reveal any evidence of device misuse or that the device was used in a manner inconsistent with the labeled indications.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, and this is no longer considered a reportable event.Additional information: block b5, h6, h10.
 
Event Description
It was reported to boston scientific corporation that two resolution 360 ultra clip devices were used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the clip grasped onto tissue, but the clip did not come out to deploy.Reportedly, it was noted that there was no click sound.It was also observed that the packaging was damaged.The same issue occurred with the second resolution 360 ultra clip.The procedure was completed with another resolution 360 ultra clip device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.The devices were returned.***additional information received on (b)(6) 2020*** it was reported that the clip was able to grasp onto the tissue, but it did not lock nor stay onto tissue.It was also noted that the packaging was not damaged.
 
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Brand Name
RESOLUTION 360 ULTRA 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 Key10774771
MDR Text Key214396162
Report Number3005099803-2020-05045
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729997252
UDI-Public08714729997252
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,foreig
Type of Report Initial,Followup
Report Date 12/03/2020
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 Date09/20/2021
Device Model NumberM00521401
Device Catalogue Number2140
Device Lot Number0025958479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Initial Date Manufacturer Received 10/09/2020
Initial Date FDA Received11/02/2020
Supplement Dates Manufacturer Received11/09/2020
Supplement Dates FDA Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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