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

Model Number	6182
Medical Device Problem Codes	Failure to Deliver Energy (1211); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of energy generating problem.Imdrf device code a0501 captures the reportable event of cautery pin detached.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used in the colon during an endoscopic colorectal polypectomy procedure performed on (b)(6) 2025.During the procedure, a connection issue with the active cord.When the cord was connected, it immediately detached and could not be used as intended.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h2 (correction): block h6 (device code) has been updated based on the information that was identified on 24jun2025.Block h6: imdrf device code a0501 captures the reportable event of cautery pin detached.Block h11: the returned rotatable snare was analyzed, the device was returned and, upon visual inspection, showed no visible damage; the cautery pin remained intact.Additionally, continuity and electrical testing were performed, and the device was found to be within specification.No other problems with the device were noted.The reported event of cautery pin detached was not confirmed.Upon analysis, the returned device did not show evidence of either the alleged problems or defects which could have contributed to the event.The device had no visible issues or damage.It was then subjected to continuity and electrical testing and found to be within specification.Additionally, the device was connected to the erbe unit (b)(6), which successfully delivered energy to the rotatable snare, indicating no issues with energy transmission.Therefore, the most probable root cause of this complaint is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable snare was used in the colon during an endoscopic colorectal polypectomy procedure performed on (b)(6) 2025.During the procedure, a connection issue with the active cord.When the cord was connected, it immediately detached and could not be used as intended.The procedure was completed with another rotatable snare.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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22152226
• Report Number: 3005099803-2025-02578
• Device Sequence Number: 8394057
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: (01)08714729283980(17)280122(10)35686645
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 6182
• Device Catalogue Number: 6182
• Device Lot Number: 0035686645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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