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

Model Number	M00561821
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	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: 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 device was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2026.During the procedure, the cautery port was not screwed in this was found during unpacking, and the device was not used.The procedure was completed with another rotatable snare 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 detached.Block h11: the returned rotatable snares was analyzed, and a visual evaluation was performed, and it was found that the cautery pin was detached from the handle.No other problems with the device were noted.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.The reported event of cautery pin detached was confirmed.Investigation found that the cautery pin was detached from the handle inside its unopen pouch.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of manufacturing deficiency.
Event or Problem Description
T was reported to boston scientific corporation that a rotatable snare device was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2026.During the procedure, the cautery port was not screwed in this was found during unpacking, and the device was not used.The procedure was completed with another rotatable snare device.

• 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: 24220575
• Report Number: 3005099803-2026-00369
• Device Sequence Number: 9385111
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: (01)08714729283980(17)280713(10)36948806
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0036948806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• 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