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

Model Number	M00535920
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on (b)(6) 2025.During the procedure, the physician preloaded an ultratome xl 30 mm cutting wire with a jagwire 0.035"/450 cm and inserted it through the working channel of the duodenoscope.Sphincterotomy was then performed using electrocautery via the erbe machine, applied through the cutting wire of the ultratome.However, approximately two minutes into the procedure, the cutting wire fractured, leading to discontinuation of its use.The procedure was completed with an alternative device there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter's address is (b)(6); reported here as the initial reporter address exceeded the character limit for the designated field.Block h2 (correction): block b5 (describe event or problem) has been corrected.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: investigation results the returned ultratome xl was analyzed, and a visual inspection found that the cutting wire was blackened, kinked and broken at 8 mm from the proximal pierce hole.Media analysis was performed based on the photo provided by the complainant, where was possible to observe the device in patient's anatomy with the cutting wire broken.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 8 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.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on (b)(6) 2025.During the procedure, the physician preloaded an ultratome xl 30 mm cutting wire with a jagwire 0.035"/450 cm and inserted it through the working channel of the duodenoscope.Sphincterotomy was then performed using electrocautery via the erbe machine, applied through the cutting wire of the ultratome.However, approximately two minutes into the procedure, the cutting wire fractured, leading to discontinuation of its use.The procedure was completed with another ultratome xl.There were no patient complications reported as a result of this event.***correction noted on december 29, 2025*** it was reported that the anatomy location of the procedure is at the ampulla.A photo of the complaint device was provided and showed the device inside the patient with the cutting wire broken.

• 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: 23501465
• Report Number: 3005099803-2025-05904
• Device Sequence Number: 12989543
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: (01)08714729103318(17)260711(10)34415738
• 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): 12/30/2025

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 Expiration Date: 07/11/2026
• Device Model Number: M00535920
• Device Catalogue Number: M00535920
• Device Lot Number: 0034415738
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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