MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 49; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: imdrf device code a0401 captures the reportable event of cutting wire break.
Event or Problem Description
This report pertains to one of two truetome 49 used in the same patient and procedure.It was reported to boston scientific corporation that a truetome 49 was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat a stricture performed on (b)(6) 2022.During the procedure, while using the sphincterotome, the cutting wire breaks suddenly, they switched to another device with the same model, but the same problem occurred.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with a third truetome 49.There were no patient complications reported as a result of this event.

• Brand Name: TRUETOME 49
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• 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: 23959991
• Report Number: 3005099803-2026-00027
• Device Sequence Number: 9528039
• Product Code: KNS
• UDI-Device Identifier: 08714729827627
• UDI-Public: (01)08714729827627(17)260726(10)34516681
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K122203
• 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
• Report Date (Section B): 01/05/2026

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 Expiration Date: 07/26/2026
• Device Model Number: M00584160
• Device Catalogue Number: M00584160
• Device Lot Number: 0034516681
• 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: 12/10/2025
• Initial Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 07/26/2024
• 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