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

Model Number	M00535920
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: imdrf device code a0401 captures the reportable event of cutting wire break.Imdrf device code a0406 captures the reportable event of cutting wire kinked.H11: investigation results: the ultratome xl device was not returned; however, a media analysis was performed based on the photo provided by the complainant where was possible to observe the cutting wire was blackened, kinked and broken.No other problems with the device were noted.With all the available information, boston scientific concludes the reported events of cutting wire break and cutting wire kinked were confirmed.According to the media analysis performed, it was found that the cutting wire was kinked and broken from 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.
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 to treat bile duct stones performed on (b)(6) 2025.During the procedure, before inserting the device into the patient, an opening and closing test had been performed without any difficulty, verifying the device functionality and integrity.However, during ercp the cutting wire broke.A photo of the complaint device was provided and showed the cutting wire was broken and kinked.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another ultratome xl.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2 (additional information): block e1 (initial reporter email) has been updated.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Imdrf device code a0406 captures the reportable event of cutting wire kinked.Block h11: investigation results the ultratome xl device was not returned; however, a media analysis was performed based on the photo provided by the complainant where was possible to observe the cutting wire was blackened, kinked and broken.No other problems with the device were noted.With all the available information, boston scientific concludes the reported events of cutting wire break and cutting wire kinked were confirmed.According to the media analysis performed, it was found that the cutting wire was kinked and broken from 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.
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 to treat bile duct stones performed on (b)(6) 2025.During the procedure, before inserting the device into the patient, an opening and closing test had been performed without any difficulty, verifying the device functionality and integrity.However, during ercp the cutting wire broke.A photo of the complaint device was provided and showed the cutting wire was broken and kinked.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another ultratome xl.There were no patient complications reported as a result of this event.

• 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: 23364398
• Report Number: 3005099803-2025-05557
• Device Sequence Number: 9931874
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: (01)08714729103318(17)270407(10)36247396
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/18/2025

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: 0036247396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/18/2025
• Date Device Manufactured: 04/07/2025
• 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: 45 YR
• Patient Sex: Male