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

Model Number	M00561831
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used in the sigmoid colon during an endoscopic colonic polypectomy procedure performed on (b)(6) 2025.During the procedure, the snare has energy generating problem.The procedure was completed with another rotatable snare.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 energy generating problem.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used in the sigmoid colon during an endoscopic colonic polypectomy procedure performed on (b)(6) 2025.During the procedure, the snare has energy generating problem.The procedure was completed with another rotatable snare.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 energy generating problem.Block h11: one rotatable snare was received for analysis, and a visual inspection revealed that the device's working length and wire were kinked at the proximal section near the strain relief.However, both continuity and electrical tests were performed, and the device was found to be within specification.Finally, the device was tested using the erbe unit (bsc0077509), and the results showed no issues with energy delivery to the rotatable snare.No other device problems were noted.The reported complaint of loop failure to deliver energy was unable to be confirmed.Upon analysis, it was observed that the working length and wire were kinked at the proximal section (strain relief).These issues likely resulted from the way the device was handled and manipulated during use.Excessive or improper manipulation without adequate care may have contributed to the defects identified.Continuity and electrical tests were performed, and the device was found to be within specification.Additionally, the device was tested using the erbe unit (bsc0077509), which successfully delivered energy to the rotatable snare.These results indicate that the device is functioning properly and that there is no issue with energy transmission.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.

• 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: 22505946
• Report Number: 3005099803-2025-03393
• Device Sequence Number: 18453311
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: (01)08714729283997(17)280425(10)36381842
• 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): 08/28/2025

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: M00561831
• Device Catalogue Number: 6183
• Device Lot Number: 0036381842
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2025
• 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