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

Device Problems Failure to Disconnect (2541); Failure to Cut (2587)

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

Event Date 06/22/2018

Event Type  malfunction  

Event Description

Cautery unit not strong enough to cut polyp properly.Physician decided to use clip to prevent any bleeding.Sheath removed to allow for rotation of clip.Once clip placed it was noticed that a portion of the sheath remained on guide and remained attached to clip.Unable to remove portion of sheath.A snare with cautery was used to melt sheath and detach it from clip.

• 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: 7663489
• MDR Text Key: 113178586
• Report Number: 7663489
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8760 DA