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

Model Number	M00561193
Medical Device Problem Codes	Failure to Cut (2587); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a sensation medium oval flexible snare was used to remove a less than 1 cm polyp in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the snare would not cut through the less than 1 cm target polyp smoothly due to the resistance felt when actuating during both hot and cold polypectomy.There was no tactile feedback according to the nurse/ tech.They checked the cautery settings, opened and closed the snares as a test to ensure they were functioning properly.They also made sure that the cautery port was connected securely to the snares and tried both hot and cold.Reportedly, no visible issues was noted with the handle.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine and stable.

• Brand Name: CAPTIVATOR II
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10302592
• Report Number: 3005099803-2020-02847
• Device Sequence Number: 689806
• Product Code: FDI
• UDI-Device Identifier: 08714729861287
• UDI-Public: 08714729861287
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133987
• 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): 07/21/2020

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: 03/18/2023
• Device Model Number: M00561193
• Device Catalogue Number: 50297
• Device Lot Number: 0025368744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1