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	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.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 in the unspecified location during an endoscopic mucosal resection procedure performed on (b)(6) 2025.According to the complainant, during the procedure, both strangulation and energization were initially performed without issue.Energization proceeded smoothly midway through the procedure.However, during the final ablation, it appeared that energization was not successfully performed.Specifically, energization could not be performed at the snare base part.As a result, strangulation was released, and the wire is pressed against the target area.Energization and resection were successfully completed.The procedure was completed with the original device.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.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used in the unspecified location during an endoscopic mucosal resection procedure performed on (b)(6) 2025.According to the complainant, during the procedure, both strangulation and energization were initially performed without issue.Energization proceeded smoothly midway through the procedure.However, during the final ablation, it appeared that energization was not successfully performed.Specifically, energization could not be performed at the snare base part.As a result, strangulation was released, and the wire is pressed against the target area.Energization and resection were successfully completed.The procedure was completed with the original device.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 h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Block h11: the returned rotatable snare device was analyzed.Functional inspection was performed, and the device was extended and retracted manually looping twice the working length in the hand, and the device could extend properly.Continuity and electrical test were conducted and the device found within specification.Lastly, the device was tested with the erbe and showed no problem supplying the energy.No other problems with the device were noted.The reported event of snare loop unable to cut and unable to deliver energy were not confirmed.During analysis, it was determined that the device did not have any visual issues or damages.The device was submitted to functional and electrical test without any issue.The unit returned did not show evidence of the alleged issue or any defect that could have contributed to the event reported.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is no problem detected.
Additional Manufacturer Narrative
Blocks d4 (model number), h6 (device codes) and h11 (investigation results) have been corrected.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.Functional inspection was performed, and the device was extended and retracted manually looping twice the working length in the hand, and the device could extend properly.Continuity and electrical test were conducted and the device found within specification.Lastly, the device was tested with the erbe and showed no problem supplying the energy.No other problems with the device were noted.The reported event of device unable to deliver energy was not confirmed.During analysis, it was determined that the device did not have any visual issues or damages.The device was submitted to functional and electrical test without any issue.The unit returned did not show evidence of the alleged issue or any defect that could have contributed to the event reported.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used in the unspecified location during an endoscopic mucosal resection procedure performed on (b)(6) 2025.According to the complainant, during the procedure, both strangulation and energization were initially performed without issue.Energization proceeded smoothly midway through the procedure.However, during the final ablation, it appeared that energization was not successfully performed.Specifically, energization could not be performed at the snare base part.As a result, strangulation was released, and the wire is pressed against the target area.Energization and resection were successfully completed.The procedure was completed with the original device.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
• 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: 23100683
• Report Number: 3005099803-2025-04661
• Device Sequence Number: 9320930
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: (01)08714729283980(17)280608(10)36714080
• 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,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2026

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: 0036714080
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 01/06/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/29/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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