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

Model Number	M00561831
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	05/27/2026
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 intended to be used in the stomach during an endoscopic mucosal resection procedure performed on (b)(6) 2026.Prior to the procedure, upon unpacking, the handle was observed to be damaged due to the cautery pin being detached.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 intended to be used in the stomach during an endoscopic mucosal resection procedure performed on (b)(6) 2026.Prior to the procedure, upon unpacking, the handle was observed to be damaged due to the cautery pin being detached.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 h2 if remedial act init, type device evaluation: the device was returned in its unopen pouch.During visual inspection it was found that the cautery pin was detached.The manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Based on the available information, the reported event of cautery pin detachment of a device component was confirmed.Boston scientific assigned the investigation conclusion code manufacturing deficiency as the root cause was traced to variability in completing the required handling and assembly steps during the manufacturing process at the supplier.As a result, reinforcement of existing manufacturing procedures has since been performed by the supplier to prevent potential reoccurrence.

• 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 lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25549123
• Report Number: 3005099803-2026-02524
• Device Sequence Number: 18831966
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: (01)08714729283997(17)280624(10)36840417
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/17/2026

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: M00561831
• Device Lot Number: 0036840417
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2026
• 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: 05/27/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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