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

Model Number	M00535920
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	11/18/2025
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 used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, when cutting the ampulla, the cutting wire of the ultratome xl broke.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 note: it was reported that the device was energized prior to bowing.; however, according to the instructions for use (ifu), 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's integrity.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block h11: (investigation result).The returned ultratome xl was analyzed, and a visual evaluation noted that the cutting wire was blackened, kinked, and broken from the proximal pierce hole.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was blackened, kinked, and broken from the proximal pierce hole.The device was energized prior to performing sphincterotomy.This condition can compromise the cutting wire integrity and cause a premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can lead to the broken section hitting the working channel of the scope.This can kink the cutting wire.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Additionally, the device was used in a manner inconsistent with a written instruction in the ifu.According to the ifu states: "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's integrity", however, the complainant reported that the device was energized prior to bowing.Based on all gathered information, the most probable root cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, when cutting the ampulla, the cutting wire of the ultratome xl broke.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.Note: it was reported that the device was energized prior to bowing.; however, according to the instructions for use (ifu), 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's integrity.

• 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 ; 9145716918
• MDR Report Key: 23764005
• Report Number: 3005099803-2025-06657
• Device Sequence Number: 18625345
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: (01)08714729103318(17)270311(10)36039698
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K930022
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: M00535920
• Device Catalogue Number: M00535920
• Device Lot Number: 0036039698
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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: 44 YR
• Patient Sex: Male