MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. BOSTON SCIENTIFIC CAPTIVATOR SNARE HEXAGONAL AND OVAL SNARE; SNARE, FLEXIBLE

Catalog Number M00562300

Device Problem Protective Measures Problem (3015)

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

Event Date 02/24/2020

Event Type  malfunction  

Event Description

Md had trouble cutting a polyp out with this snare(s) and verbalized safety concerns with the snare(s).Fda safety report id # (b)(4).

• Brand Name: BOSTON SCIENTIFIC CAPTIVATOR SNARE HEXAGONAL AND OVAL SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 9780137
• MDR Text Key: 182219086
• Report Number: MW5093490
• Device Sequence Number: 2
• 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: 02/28/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: M00562300
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2020
• 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: 52