MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC CAPTIVATOR II; SNARE, NON-ELECTRICAL

Model Number REF: M00561220

Device Problem Failure to Cut (2587)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

We are using boston scientific snares, am told that we are having issues with the snares not cutting through polyps causing clips to be placed at the polyp site, to stop the bleeding.We tried four different snares two different lot numbers still having the same problem.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC CAPTIVATOR II
• Type of Device: SNARE, NON-ELECTRICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; marlborough MA 01752
• MDR Report Key: 11272292
• MDR Text Key: 230328345
• Report Number: MW5099149
• Device Sequence Number: 1
• Product Code: FDI
• 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: 01/29/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2023
• Device Model Number: REF: M00561220
• Device Lot Number: 25959071
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2021
• 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: 72 YR
• Patient Weight: 87