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

Model Number	M00561831
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	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare device was used for a polyp in the colon during a polypectomy procedure performed on (b)(6) 2026.During the procedure, the device was unable to deliver energy.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 unable to deliver energy.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a090402 captures the reportable event of device unable to deliver energy.Block h11: investigation results- the returned rotatable snares device was analyzed, and a visual evaluation noted that the working length and wire were kinked; also, the loop was able to be extended.An electrical test was performed, and the device was found within specification.No other problems with the device were noted.The reported event of device unable to deliver energy was not confirmed.It was found that the working length and wire were kinked.This problem likely has occurred due to the manner in which the device was handled and manipulated, which may have caused the reported and encountered problem.Excessive manipulation of the device without enough care could have induced the defect found.Regarding the reported problem of the device being unable to deliver energy, due to the product analysis performed, it was found that the loop was able to be extended and the continuity and electrical test performed on the device were found within specifications.Since the device cannot be functionally tested by emulating the anatomical or procedural factors encountered during the procedure, 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 device was used for a polyp in the colon during a polypectomy procedure performed on (b)(6) 2026.During the procedure, the device was unable to deliver energy.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; propark, coyol; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24202428
• Report Number: 3005099803-2026-00337
• Device Sequence Number: 9809849
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: (01)08714729283997
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: M00561831
• Device Catalogue Number: 6183
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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