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

Model Number	M00561831
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Facility name: (b)(6) hospital.Facility address: (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 med stiff snare was prepared for use during a polypectomy procedure performed on (b)(6) 2021.It was reported that before performing the polypectomy procedure, the staff checked if the snare would extend/deploy.When the loop was checked, it could not be used because it was torn/broken from the tip part of the loop.The torn/broken part of the loop wire (tip) appeared to be burnt black.The procedure was completed with another rotatable snare.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 stable.
Additional Manufacturer Narrative
Block e1: (facility name) (b)(6) block e1: (facility address) (b)(6) block h6: problem code a0401 captures the reportable event of snare loop broken.Block h10: (product investigation) one rotatable snare was received for analysis.A visual inspection noted the loop was broken and with evidence of blackened wire (burned).The reported event of loop break was confirmed.This failure may occur due to an excessive application of power during the cauterization process, which causes an overheating of the wire and finally it breaks.The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Therefore, taking into consideration the evaluation conducted at the complaint investigation site and the details of the complaint, this investigation is assigned the most probable conclusion code of adverse event related to procedure.This is defined as a complaint were an adverse event occurred during the procedure and the device had no influence on the event.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 med stiff snare was prepared for use during a polypectomy procedure performed on (b)(6), 2021.It was reported that before performing the polypectomy procedure, the staff checked if the snare would extend/deploy.When the loop was checked, it could not be used because it was torn/broken from the tip part of the loop.The torn/broken part of the loop wire (tip) appeared to be burnt black.The procedure was completed with another rotatable snare.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 stable.

• 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: 11671636
• Report Number: 3005099803-2021-01558
• Device Sequence Number: 16889560
• 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): 05/13/2021

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: 10/21/2023
• Device Model Number: M00561831
• Device Catalogue Number: 6183
• Device Lot Number: 0026221907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1