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

Model Number	M00561831
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable medium oval stiff snare was used in the colon during an endoscopic polypectomy procedure performed on (b)(6) 2021.During the procedure, the device was unable to deliver energy during polyp resection.Reportedly, it was confirmed on both the snare handle and the machine side that the snare was securely attached to the active cord.After the procedure was completed, the machine was checked, but there was no problem.There were no visible issue noted with the cautery pin.There was an attempt to apply cautery and there were no other issues noted with the device.The procedure was completed with a different device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: (initial reported city) (b)(6).Block h6: problem code a090402 captures the reportable event of difficulty delivering electric current.Block h10: (product investigation): one rotatable snare was received for analysis.The device was carefully inspected and no damages were noted.Continuity test was performed and the device's electrical resistance was within specification which measured 19.1 ohms (the resistance shall be less than 20 ohms), indicating a proper connection.Taking into consideration the evaluation conducted at the complaint investigation site and the details of the complaint, this product investigation was assigned the most probable cause classification of no problem detected.This code was selected as the most probable complaint cause based on the information available.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found no issues with the device during visual and continuity test.No issues were noted with the electrical device testing during continuity test.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable medium oval stiff snare was used in the colon during an endoscopic polypectomy procedure performed on (b)(6), 2021.During the procedure, the device was unable to deliver energy during polyp resection.Reportedly, it was confirmed on both the snare handle and the machine side that the snare was securely attached to the active cord.After the procedure was completed, the machine was checked, but there was no problem.There were no visible issue noted with the cautery pin.There was an attempt to apply cautery and there were no other issues noted with the device.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

• 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: 11702074
• Report Number: 3005099803-2021-01831
• Device Sequence Number: 19698151
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: 08714729283997
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 06/23/2023
• Device Model Number: M00561831
• Device Catalogue Number: 6183
• Device Lot Number: 0025632345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1