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

Device Problem Failure to Form Staple (2579)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/02/2018

Event Type  malfunction  

Event Description

Patient presented for screening colonoscopy, polyps removed, and the patient was discharged.The patient returned to the ed 2 days later due to rectal bleeding, and a repeat colonoscopy was performed.Several clips had fallen off prematurely.Six clips were then applied.

• Brand Name: RESOLUTION 360 CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7998963
• MDR Text Key: 124861052
• Report Number: 7998963
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27010 DA