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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event loop cutting issue.Imdrf device code a090402 captures the reportable event of energy generating issue.
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) 2023.During the procedure, a new rotatable snare was opened and looped around a polyp.When the snare was energized to induce cautery and cutting, it did not work.The procedure was completed with a similar rotatable snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event loop cutting problem.Imdrf device code a090402 captures the reportable event of energy generating problem.Block h10 investigation results: one rotatable snare was received for analysis.Visual and microscope analysis of the returned device found the working length was detached from the proximal section.Electrical analysis cannot be performed due to the condition of the device.No other problems were noted.The reported events of "loop failure to cut" and "device failure to deliver energy could not be confirmed since the electrical test cannot be performed due to the condition of the device.Device analysis found that the working length was detached.It is likely that this is due to an excess of manipulation of the device.It is most likely that during manipulation of the device an excess of force was applied to the device such as the interaction with the scope or additional tools/medical devices, causing the device to separate in two pieces.Therefore, based on analysis of the returned device and all available information, the most probable cause for the reported event is adverse event related to procedure.
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) 2023.During the procedure, a new rotatable snare was opened and looped around a polyp.When the snare was energized to induce cautery and cutting, it did not work.The procedure was completed with a similar rotatable snare.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
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17342954
• Report Number: 3005099803-2023-03855
• Device Sequence Number: 6893743
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: 08714729283997
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 05/04/2026
• Device Model Number: M00561831
• Device Catalogue Number: 6183
• Device Lot Number: 0031564230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown