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

Model Number	M00561821
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	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: imdrf device code a090402 captures the reportable event of unable to deliver energy.Imdrf device code a050702 captures the reportable event of loop unable to cut.
Event or Problem Description
It was reported to boston scientific that a rotatable snare was used in the large intestine during endoscopic polypectomy and mucosal resection of the stomach and duodenum procedure for colonic adenoma performed on (b)(6) 2025.During the procedure, while inside the patient, there was poor puncture of resection of a 10mm and 23mm polyps.The procedure was completed with the original device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of unable to deliver energy.Imdrf device code a050702 captures the reportable event of loop unable to cut.Block h11: the returned rotatable snare was analyzed.The device was returned, it was observed that the working length and wire were kinked at the proximal section (strain relief).The loop was also able to be extended.However, continuity and electrical testing were performed, and the device was found to be within specification.No other problems with the device were noted.The reported events of unable to deliver energy and loop unable to cut were not confirmed.It was found that the working length and the wire were kinked at the proximal section (strain relief).These issues likely occurred due to the manner in which the device was handled and manipulated.Excessive manipulation of the device without sufficient care may have contributed to the defects observed.Based on the product analysis performed on the device, the continuity and electrical tests were found to be within specifications.Based on all available information, the probable root cause assigned is device problem excluded.
Event or Problem Description
It was reported to boston scientific that a rotatable snare was used in the large intestine during endoscopic polypectomy and mucosal resection of the stomach and duodenum procedure for colonic adenoma performed on (b)(6) 2025.During the procedure, while inside the patient, there was poor puncture of resection of a 10mm and 23mm polyps.The procedure was completed with the original device.There were no patient complications 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23888712
• Report Number: 3005099803-2025-06878
• Device Sequence Number: 4771145
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: (01)08714729283980(17)280730(10)37106595
• 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): 02/23/2026

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: 0037106595
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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 Age: 68 YR
• Patient Sex: Male