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	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used for colorectal tumor in the colon during a colorectal polypectomy procedure performed on (b)(6) 2026.During the procedure, the energization output appeared weak even though the snare was securely connected to the active cord.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Block h11: investigation results the returned rotatable snare device was analyzed, and a visual evaluation noted that the working length (strain relief) was bent.The electrical test was performed, and the device was found within specification and also showed continuity.The tip of the loop had procedure material.The device was tested with the erbe, and as a result, the erbe shows no problem supplying the energy to the rotatable snare.No other problems with the device were noted.It was confirmed this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations which could have contributed to the reported event.The reported event of snare unable to deliver energy was not confirmed.Investigation found that the working length (strain relief) was bent.This failure likely has occurred due to the manner in which the device was handled and manipulated, which may have caused the reported and encountered failure.Excessive manipulation of the device without enough care could have induced the defect found.A continuity and electrical test was performed, and it was found that the device was within specifications.Also, the device was tested with the erbe plugged into it, and the erbe shows no problem supplying the energy to the snare.Taking all available information into consideration, the most probable cause of this complaint is device problem excluded.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used for colorectal tumor in the colon during a colorectal polypectomy procedure performed on (b)(6) 2026.During the procedure, the energization output appeared weak even though the snare was securely connected to the active cord.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 24305464
• Report Number: 3005099803-2026-00545
• Device Sequence Number: 5315217
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: (01)08714729283980(17)280922(10)37525633
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 0037525633
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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 Sex: Unknown