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

Model Number	M00561241
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
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
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-05225 for the associated device information.It was reported to boston scientific corporation that a captivator snare was used in the colon during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the snare initially cauterized with current as usual however mid-way through the cut, it has lost the ability to conduct current.Despite confirming good contact of the grounding pad, the active chord and the proper settings with this generator and a subsequent generator, no current could be re-established using this snare.Reportedly, there were no visible issues with the cautery pins and the device.Initially, signs of cautery were noted (tissue turning white), however, it stopped.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 10823938
• Report Number: 3005099803-2020-05224
• Device Sequence Number: 3800119
• Product Code: FDI
• UDI-Device Identifier: 08714729855927
• UDI-Public: 08714729855927
• 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): 11/11/2020

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: 08/21/2022
• Device Model Number: M00561241
• Device Catalogue Number: 6124
• Device Lot Number: 0024313830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1