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

Model Number	M00561821
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of loop break.
Event or Problem Description
It was reported to boston scientific corporation that a rotatebl snare device was used in the colon for colorectal polyp during a polypectomy procedure performed on (b)(6) 2024.During the procedure, the loop wire was damaged.The procedure was completed with another 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 device was used in the colon for colorectal polyp during a polypectomy procedure performed on (b)(6) 2024.During the procedure, the loop wire was damaged.The procedure was completed with another device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of loop break.Block h11: investigation results a rotatable snare was received for analysis, and it was found during visual inspection that the working length and wire were kinked at proximal section.Additionally, the loop was inspected, and it was not broken.No other problems with the device were noted.The reported complaint of loop break was unable to be confirmed.During analysis of the device, it was found that the working length and the wire were kinked at proximal section; however, no breaks were observed.It is probable that the handling of the device could have caused or contributed to the observed kink.Based on the information available and the returned device analysis, since no breaks were observed, a conclusion of no problem detected was assigned to this investigation since the reported allegation was not observed.

• 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: 21123648
• Report Number: 3005099803-2024-06913
• Device Sequence Number: 18062214
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: 08714729283980
• 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): 03/24/2025

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: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0033955387
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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