MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Rotatable Snare; Snare, Flexible

Model Number	M00561821
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of cautery pin detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used in the colon during a polypectomy procedure performed on (b)(6) 2026.During the procedure, the parameters of the energy platform were set routinely but after attempting to use energy from the snare, the cautery pin was fractured abnormally after polyp resection the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used in the colon during a polypectomy procedure performed on (b)(6) 2026.During the procedure, the parameters of the energy platform were set routinely but after attempting to use energy from the snare, the cautery pin was fractured abnormally after polyp resection the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of cautery pin detachment of device or device component.Correction: block h7 if remedial act init, type.Device evaluation: the device was not returned for analysis; therefore, a technical analysis could not be performed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on a thorough review of the reported complaint, the most probable cause of the reported issue cannot be established due to lack of evidence.Since the investigation findings do not lead to a clear conclusion about the cause of the reported event; boston scientific has assigned an investigation conclusion code of cause not established.

• 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 ; +1(914)571-6918
• MDR Report Key: 25665605
• Report Number: 3005099803-2026-02621
• Device Sequence Number: 5596225
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: (01)08714729283980(17)280911(10)37445419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: M00561821
• Device Lot Number: 0037445419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 09/12/2025
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Weight: 134 LB