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

Model Number	M00561820
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	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used during an unknown procedure performed on (b)(6) 2025.During preparation, the connector for the electrosurgery cable in the handle was missing, making it unusable.The connector was present in the bag but had not been installed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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 ; 9145716918
• MDR Report Key: 23728372
• Report Number: 3005099803-2025-06602
• Device Sequence Number: 10258815
• Product Code: FDI
• UDI-Device Identifier: 08714729747703
• UDI-Public: (01)08714729747703(17)280803(10)37129103
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 12/05/2025

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: M00561820
• Device Catalogue Number: M00561820
• Device Lot Number: 0037129103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• 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