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

Model Number 360

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Resolution clip boston scientific lot #27394133, ref #m00521230, exp-5/11/2024 fail to attach to the patients gastric wall.Notified and the item given to (b)(6).Fda safety report id# (b)(4).

• Brand Name: RESOLUTION 360 CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12307037
• MDR Text Key: 266210054
• Report Number: MW5103143
• Device Sequence Number: 1
• Product Code: PKL
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 360
• Device Catalogue Number: M00521230
• Device Lot Number: 27394133
• 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