MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESOLUTION 360 ULTRA CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number M00521402

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.Medwatch number is mw5112388.(b)(4).

Event Description

It was reported to boston scientific corporation that a resolution 360 ultra clip device was used during a procedure performed on an unknown date.During the procedure, the clip did not come off the deployment system.The clip finally came off the deployment system but fell off from the deployment site.It was reported that the device got stuck inside the scope and was difficult to remove.Eventually, the physician was able to successfully pull the device out of the scope.No further information has been obtained despite good faith efforts.There were no patient complications have been reported due to this event.

• 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
• 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 Key: 15787500
• MDR Text Key: 307806148
• Report Number: 3005099803-2022-06447
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729997269
• UDI-Public: 08714729997269
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521402
• Device Catalogue Number: 2140
• Device Lot Number: 0028414642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1