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

Model Number	M00561821
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of device failed to deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare device was used for polypectomy during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the coagulation did not work at all.The cautery did not travel to the polyp site.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of device failed to deliver energy.Block h11: investigation results a rotatable snare was received for analysis, and it was found during device analysis that the device was returned without any visible problem.A continuity and electrical test were performed, and the device was noted to be within specification.Additionally, the device was tested, and as a result, the erbe shows no problem supplying the energy to the rotatable snare.No other problems with the device were noted.The reported complaint of device failed to deliver energy was unable to be confirmed.The unit returned did not show evidence of the alleged issue or any defect that could have contributed to the event reported.Based on the information available and the returned device analysis, a conclusion of no problem detected was assigned to this investigation since the reported allegation was not observed.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare device was used for polypectomy during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the coagulation did not work at all.The cautery did not travel to the polyp site.The procedure was completed with another 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21877674
• Report Number: 3005099803-2025-01649
• Device Sequence Number: 18072270
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: (01)08714729283980(17)251219(10)30748525
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/18/2025

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 Expiration Date: 12/19/2025
• Device Model Number: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0030748525
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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