Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; CLIP, HEMOSTATIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION RESOLUTION CLIP; CLIP, HEMOSTATIC Back to Search Results
Model Number M00522610
Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022.During the procedure, the wound was closed with the clip.After the outer sheath was removed, the delivery shaft was twisted and kinked, and the clip could not be deployed.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
Block h6: imdrf device code a15 captures the reportable event of clip could not be deployed.Block h10: investigation results: the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned with its over sheath and with the clip assembly attached.Additionally, no kinks were found in the catheter.Microscope examination was performed, and it was found both activations performed and deployed inside the over sheath.No other problems with the device were noted.The reported event of clip unable to release from the catheter was not confirmed.Investigation found that the device returned with the clip released from the catheter inside the over sheath.Evidence that the clip was able to release.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 device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
Event Description
It was reported to boston scientific corporation that a resolution clip device was used in the stomach during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022.During the procedure, the wound was closed with the clip.After the outer sheath was removed, the delivery shaft was twisted and kinked, and the clip could not be deployed.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key16120788
MDR Text Key307993012
Report Number3005099803-2022-07941
Device Sequence Number1
Product Code PKL
UDI-Device Identifier08714729504795
UDI-Public08714729504795
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K222503
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 02/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2023
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 Number0029673855
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2022
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 Weight52 KG
-
-