MAUDE Adverse Event Report: BOSTON SCIENTIFIC RESOLUTION 360CLIP; RESOLUTION 360 CLIP

Model Number M000521230

Device Problems Separation Failure (2547); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2017

Event Type  malfunction  

Event Description

While trying to remove colon polyp the resolution 360 clipping device fired clip but would not disengage.

• Brand Name: RESOLUTION 360CLIP
• Type of Device: RESOLUTION 360 CLIP
• Manufacturer (Section D): BOSTON SCIENTIFIC; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6669470
• MDR Text Key: 78465380
• Report Number: 6669470
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/06/2018
• Device Model Number: M000521230
• Device Catalogue Number: M000521230.
• Device Lot Number: 0000058090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR