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

Model Number	M00561191
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-05064 for the associated device information.It was reported to boston scientific corporation that a captivator ii-25mm round stiff snare was used to remove polyps during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the first snare worked upon first cut but then failed to cauterize upon further attempts.The generator was switched for another and the same snare was used, but did not result in a successful cut.A second captivator snare with the same size was opened and it worked for two cuts but then, it also failed after.A third captivator snare of a different size was then used successfully to complete the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 10791228
• Report Number: 3005099803-2020-05065
• Device Sequence Number: 1047599
• Product Code: FDI
• UDI-Device Identifier: 08714729855934
• UDI-Public: 08714729855934
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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: 02/10/2023
• Device Model Number: M00561191
• Device Catalogue Number: 6119
• Device Lot Number: 0025195593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/05/2020
• Patient Sequence Number: 1