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

Model Number	M00535900
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	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.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 attempted to be used in the common bile duct (cbd) during endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile was not coming from bile duct performed on an unknown date.During the procedure, after opening the device package, the physician noticed the cutting wire was broken.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient's condition was expected to fully recover.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was attempted to be used in the common bile duct (cbd) during endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile was not coming from bile duct performed on an unknown date.During the procedure, after opening the device package, the physician noticed the cutting wire was broken.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient's condition was expected to fully recover.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: investigation results- the ultratome xl device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, response was not received.However, a media analysis was performed on the photo provided by the complainant.The photo revealed that the cutting wire was broken and kinked.No other problems with the device were noted.According to the media analysis performed, it was observed that the cutting wire was broken and kinked, however, there is not enough evidence to determine whether the issues were induced due to the physician's technique during the procedure or were related to a device malfunction.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.

• 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: 24431773
• Report Number: 3005099803-2026-00708
• Device Sequence Number: 16026703
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: (01)08714729103257(17)261126(10)35373563
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 05/25/2026

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: 0035373563
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 05/01/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/01/2026; 05/25/2026
• Date Device Manufactured: 11/26/2024
• 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