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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6) hospital; reported here as the name exceeded character limit for designated field.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 used in the duodenal papillary sphincter during an endoscopic sphincterotomy (est) procedure to treat common bile duct stones performed on (b)(6) 2026.During the procedure, the patient underwent resection of a lesion at the duodenal papilla.While performing the incision of the duodenal papillary sphincter, the cutting wire at the tip of the device suddenly broke, making it impossible to continue the incision.The procedure was paused for 20 minutes to allow for device exchange, after which it resumed.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the device was energized prior to bowing and the device was energized when not in contact with tissue."per the instructions for use (ifu), precaution: the sphincterotome does not need to be energized prior to performing sphincterotomy.Energizing the cutting wire prior to use will cause premature cutting wire fatigue and will compromise the cutting wire integrity." and 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: 24976046
• Report Number: 3005099803-2026-01500
• Device Sequence Number: 10479967
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: (01)08714729103257(17)270525(10)36602126
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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: 0036602126
• Was Device Available for Evaluation?: No
• 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: 03/29/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 05/25/2025
• 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 Age: 59 YR
• Patient Sex: Female