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

Model Number M00521230

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e0506 captures the reportable event of major hemorrhage.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.

Event Description

Note: this report pertains to one of two resolution 360 clips used in the same patient and procedure.It was reported to boston scientific corporation that two resolution 360 clips devices were used during a colonoscopy procedure for post polypectomy closure performed on (b)(6) 2024.During the procedure, two clips were placed on a 1.5cm post polypectomy site.The procedure was completed successfully, and no bleeding was observed.It was reported that the patient never stopped aspirin prior to procedure and continued the aspirin after the procedure.Five days later, the patient reported acute bleeding and returned for a repeat colonoscopy.The physician discovered minor bleeding outside of the deployed clips.Both clips were still in place with tamponade.The physician went ahead and placed more clips at the bleeding site.The patient has fully recovered.

• 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: 18760281
• MDR Text Key: 336014803
• Report Number: 3005099803-2024-00680
• Device Sequence Number: 1
• Product Code: PKL
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• 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: 01/29/2024
• 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
• Patient Outcome(s): Required Intervention