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	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6).Block h6: imdrf device code a0401 captures the reportable event of a wire break.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the cutting wire was broke.It was reported that no part of the device was detached and fell inside the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: the complainant reported that the device was energized prior to bowing; however, 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's integrity.
Additional Manufacturer Narrative
Block e1: (b)(6).Block g2: block b5 has been updated based on the additional information received on february 10, 2026.Block h6: imdrf device code a0401 captures the reportable event of a wire break.Block h11: the returned ultratome xl was analyzed, and visual inspection that the cutting wire was blackened, kinked and broken at 5 mm from the proximal pierce hole.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break was confirmed.The results of the analysis performed on the returned device found that the cutting wire was kinked and broken at 5 mm from the proximal pierce hole.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.The break in the cutting wire could have been generated if there was contact between the device and the scope during energization or if the device exceeded the maximum of voltage during procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wires integrity, causing premature cutting wire fatigue.Once the cutting wire breaks, any attempt to remove the device from the scope can bend the cutting wire as observed in the product analysis.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the cutting wire was broke.It was reported that no part of the device was detached and fell inside the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: the complainant reported that the device was energized prior to bowing; however, 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's integrity.Additional information was received on february 10,2026.It was reported that the device was not energized prior to bowing.

• 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: 24234176
• Report Number: 3005099803-2026-00381
• Device Sequence Number: 10175409
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: (01)08714729103257(17)270127(10)35718984
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 0035718984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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
• Patient Weight: 60 KG