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

Model Number	M00561831
Medical Device Problem Codes	Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event unable to cut.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used in the colon for multiple polyps during a polypectomy procedure performed on (b)(6) 2025.During the procedure, the polyp could not be removed after the device was fixed on the polyp site.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used in the colon for multiple polyps during a polypectomy procedure performed on (b)(6) 2025.During the procedure, the polyp could not be removed after the device was fixed on the polyp site.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on february 6, 2025.The type of polyp removed was a proliferatve pedicled polyp with the size of 1.2 cm.
Additional Manufacturer Narrative
Blocks a1 (patient identifier), b5, e1 (initial reporter address 1, initial reporter address 2, initial reporter city, and initial reporter zip/post code) have been updated based on the additional information received on (b)(6) 2025.Block h6: imdrf device code a050702 captures the reportable event unable to cut.Block h11: investigation results the returned rotatable snare was analyzed, and a visual evaluation noted that the flare was detached from the working length (strain relief).Also, the device was checked under magnification, and it is important to mention that the working length had evidence of the flare being made.In addition, the working length and wire were kinked at proximal section (strain relief), this torn the sheath in this same section.Due to the device condition the functional, continuity and electrical test could not be performed.No other problems with the device were noted.The reported event of loop unable to cut was confirmed.Upon analysis, it was found that the device had the flare detached from the working length (strain relief), due to this condition the loop could not extend.The damage found in the flare suggests that it was manipulated.Also, it was found that the working length and wire were kinked at proximal section, this torn the sheath in this same section.These problems likely have occurred due to the manner as the device was handled and manipulated which may have caused the reported and encountered problems.Excessive manipulation of the device without enough care could have induced the defects found.Therefore, the most probable root cause of this complaint is adverse event related to procedure.

• 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: 21265257
• Report Number: 3005099803-2025-00244
• Device Sequence Number: 11896761
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: 08714729283997
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/03/2025

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: M00561831
• Device Catalogue Number: 6183
• Device Lot Number: 0032773604
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 68 KG