MAUDE Adverse Event Report: BOSTON SCIENTIFIC RESOLUTION 360 CLIP; HEMOSTATIC METAL CLIP FOR G1

Catalog Number M00521230

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/12/2017

Event Type  malfunction  

Event Description

Used to clip a gastric bypass.It was attached but fell off from the gastric polyp site and it was seen on the patient's stomach with no tissue attached on the clip.Unable to retrieve from the patient.

• Brand Name: RESOLUTION 360 CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR G1
• Manufacturer (Section D): BOSTON SCIENTIFIC; jeffersonville IN 47130
• MDR Report Key: 6721555
• MDR Text Key: 80493627
• Report Number: MW5071070
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2020
• Device Catalogue Number: M00521230
• Device Lot Number: 0000065050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 117