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

Model Number M00521230

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Imdrf device code a15 captures the reportable event of clip difficult to release from the catheter.

Event Description

It was reported to boston scientific corporation that a resolution 360 clip device was used during a procedure performed on (b)(6) 2023.During the procedure, the clip was able to grasp and lock onto tissue; however, when they went to deploy the clip, the spool snapped, and they were unable to complete the last step.Eventually, the clip detached after they were able to rotate at the biopsy cap and the procedure was completed at this time.There were no patient complications reported as a result of this event.

• 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
• 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: 16628859
• MDR Text Key: 312163935
• Report Number: 3005099803-2023-01639
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 08714729875628
• UDI-Public: 08714729875628
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00521230
• Device Catalogue Number: 54772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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