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

Model Number	M00561821
Medical Device Problem Codes	Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a090402 captures the reportable event of energy generating problem.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used in the colon during a polypectomy procedure performed on (b)(6) 2024.During the procedure, it was reported that energization could not be performed.The procedure was completed with another rotatable small oval med stiff snare device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H6: imdrf device code a090402 captures the reportable event of energy generating problem.H11 investigation results: one rotatable snare was received for analysis.Visual analysis of the returned device was found the device returned and it was found during visual inspection that the tip of the loop was blackened, the device was checked under magnification, and it was found that some wire braids were melted.These are signals that the device could conduce the electrical current.A continuity and electrical test were performed, and the device was found within specification.No other problems were noted.The reported event of "device failure to deliver energy" could not be confirmed.It was found that the tip of the loop was blackened, and some wire braids were melted.This issue could have been induced due to an excessive time of energization or an excessive electrical current applied.Excessive manipulation of the device without enough care could have induced the defect found as well.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used in the colon during a polypectomy procedure performed on (b)(6) 2024.During the procedure, it was reported that energization could not be performed.The procedure was completed with another rotatable small oval med stiff snare 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20471392
• Report Number: 3005099803-2024-05211
• Device Sequence Number: 20646726
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: 08714729283980
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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 Model Number: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0034105074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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