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

Model Number	M00535900
Medical Device Problem Codes	Failure to Fold (1255); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the device did not bow at the time of cutting.It was reported that the cutting wire appeared deform.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: photo of the complaint device outside the patient was provided by the customer and shows the cutting wire kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a04061 captures the reportable event of cutting wire kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a04061 captures the reportable event of cutting wire kinked.Block h11: (investigation result).Media evaluation noted that the cutting wire was slightly bent.No other problems with the device were noted.The reported event of cutting wire kinked was confirmed.Upon analysis of the provided picture, it was found that the cutting wire was slightly bent however, the most probable cause of the observed and the reported problem cannot be established due to lack of evidence.The product was not returned for analysis to identify any problem with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Therefore, the most probable root cause could not be established.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the device did not bow at the time of cutting.It was reported that the cutting wire appeared deform.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event note: photo of the complaint device outside the patient was provided by the customer and shows the cutting wire kinked.

• 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: 23845351
• Report Number: 3005099803-2025-06794
• Device Sequence Number: 9572122
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: (01)08714729103257(17)270630(10)36869366
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: 0036869366
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/15/2026
• Date Device Manufactured: 06/30/2025
• 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