MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC COLD 10MM CAPTIVATOR THIN WIRE; SNARE, FLEXIBLE

Model Number GTIN 08714729971252

Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

During colonoscopy, md using a cold snare to remove polyp.On the second opening the device was bent and would not open correctly.Staff removed the snare from scope and obtained a new piece of equipment that would open and close properly.Fda safety report id # (b)(4).

• Brand Name: BOSTON SCIENTIFIC COLD 10MM CAPTIVATOR THIN WIRE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12569026
• MDR Text Key: 274737323
• Report Number: MW5104345
• Device Sequence Number: 1
• Product Code: FDI
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GTIN 08714729971252
• Device Catalogue Number: REF M00561100
• Device Lot Number: 27716100
• 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