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

Model Number	M00562391
Medical Device Problem Codes	Failure to Deliver Energy (1211); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to be (b)(6) 2019 as no event date was reported.(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a captivator lg oval thin wire flex snare was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the device failed to deliver energy and the snare loop became stuck in the mucosa.Reportedly, the snare loop had to be cut to remove the device and it was unknown what device was used to remove the snare loop.Reportedly, there were no visible issues noted with the cautery pin and the snare was securely attached to the active cord.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.

• Brand Name: CAPTIVATOR
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8297246
• Report Number: 3005099803-2019-00318
• Device Sequence Number: 16697009
• Product Code: FDI
• UDI-Device Identifier: 08714729019404
• UDI-Public: 08714729019404
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2021
• Device Model Number: M00562391
• Device Catalogue Number: 6239
• Device Lot Number: 0022045780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1