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

Model Number	M00535900
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is high-tech branch of (b)(6) hospital (b)(6); reported here as initial reporter facility name exceeded the character limit for the designated field.The initial reporter address is at the intersection of (b)(6); reported here as initial reporter address exceeded the character limit for the designated field.Block h6: imdrf device code a040601 captures the reportable event of cutting wire kinked.Block h11: investigation results the ultratome xl device was not returned for analysis; therefore, a technical analysis could not be performed.A media analysis was performed on the photo provided by the complainant.The photo revealed that the device without the mandrel and the cutting wire kinked.No other problems with the device were noted.According to the media analysis performed, it was found that the device without the mandrel and with the cutting wire kinked, however, there is not enough evidence to determine whether the problem was induced due to the physician's technique during unpacking or was 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.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was unpacked to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat intestinal obstruction performed on (b)(6) 2026.During unpacking, it was noticed that the cutting wire extended out.A photo was provided from the customer showing that the cutting wire was kinked.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.

• 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: 24942571
• Report Number: 3005099803-2026-01458
• Device Sequence Number: 21064489
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: (01)08714729103257(17)270714(10)36964450
• 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
• Report Date (Section B): 04/21/2026

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: 0036964450
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 07/14/2025
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 54 KG