MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR HEXAGONAL SNARE BOSTON SCIENTIFIC; SNARE, FLEXIBLE

Model Number M00562450

Device Problem Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2022

Event Type  malfunction  

Event Description

Patient had a large pedunculated polyp to be removed.Hexagonal boston scientific snare with erbe cautery unit used.Hexagonal snare would not cut or cauterize polyp.Erbe unit was checked by biomed 01/2022.A different type of snare was utilized and was able to be cut and cauterized.Contacted boston scientific representative, after review of information, new connection cords to share were replaced on cautery unit on 03/16/2022.These type of snares have been in use since 2017 with no deviation from standard performance.Fda safety report id # (b)(4).

• Brand Name: CAPTIVATOR HEXAGONAL SNARE BOSTON SCIENTIFIC
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13863524
• MDR Text Key: 287842288
• Report Number: MW5108468
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562450
• Device Lot Number: 28201832
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 138 KG
• Patient Ethnicity: Non Hispanic