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

Model Number M00521402

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

Note: this report pertains to the one of two resolution 360 ultra clips that were used in the same procedure.It was reported to boston scientific corporation that a resolution 360 ultra clip device was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip could not detach from the catheter to deploy.The physician attempted to open and close the handle multiple times but was unsuccessful.The device was forcefully pulled out.The procedure was completed with another resolution 360 ultra clip and a non-bsc clip.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of clip unable to release from catheter.

• 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: 16814642
• MDR Text Key: 313998975
• Report Number: 3005099803-2023-02045
• 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: K222503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• 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: 0030732691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2022
• 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