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	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was attempted to be used in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat bile duct stones performed on (b)(6) 2026.During the procedure, when cutting the duodenal papilla, the cutting wire was fractured.It was reported that the cutting wire was intact, but the wire anchor dislodged from the catheter.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.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is the (b)(6) hospital of (b)(6); reported here as initial reporter facility name exceeded the character limit for the designated field.Block h6: imdrf device code a040601 captures the reportable event of wire/anchor dislodged or dislocated.

• 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: 24796022
• Report Number: 3005099803-2026-01238
• Device Sequence Number: 9548126
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: (01)08714729103257(17)261015(10)35073077
• 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,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: 0035073077
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/25/2026
• Date Device Manufactured: 10/15/2024
• 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 Age: 71 YR
• Patient Sex: Unknown
• Patient Weight: 60 KG