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

Model Number	M00561831
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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
It was reported to boston scientific corporation that a rotatable medium oval med stiff snare was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the snare failed to cauterize and cut through the polyp.Reportedly, the snare was securely attached to the active cord and there was no visible issue noted with the cautery pin.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: ROTATABLE SNARE
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8892896
• Report Number: 3005099803-2019-03891
• Device Sequence Number: 18892381
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: 08714729283997
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160637
• 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): 08/14/2019

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: 02/19/2022
• Device Model Number: M00561831
• Device Catalogue Number: 6183
• Device Lot Number: 0023376709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1