MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Ultratome XL; Snare, Flexible

Model Number	M00535900
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was attempted to be used during an endoscopic sphincterotomy (est) procedure to performed on (b)(6) 2026.During the procedure, it was discovered that the tip wire at the front of the knife broke.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with a non-bsc device.There were no patient complications reported as a result of this event.Note: it was reported that the device was energized when not in contact with tissue.Per the instructions for use (ifu), precaution: it is recommended to maintain direct and constant contact with tissue when applying electrocautery current.Failure to do so may result in broken cut wire, damage to the endoscope and/or patient injury.

• Brand Name: Ultratome XL
• 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 ; +1(914)571-6918
• MDR Report Key: 25721926
• Report Number: 3005099803-2026-02679
• Device Sequence Number: 20255667
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: (01)08714729103257(17)271110(10)37927070
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K930022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2026

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: M00535900
• Device Catalogue Number: M00535900
• Device Lot Number: 0037927070
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Supplement Date Received by Manufacturer: 07/09/2026; 08/24/2026
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 07/21/2026; 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• 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