MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of a wire break.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 39 was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat obstruction performed on (b)(6) 2026.During the procedure, when the tome was bowed and cautery applied for sphincterotomy, the wire broke.It was reported that no part of the device was detached and fell inside the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition was reported to be fully recovered.

• Brand Name: TRUETOME 39
• 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: 24234859
• Report Number: 3005099803-2026-00384
• Device Sequence Number: 18699500
• Product Code: KNS
• UDI-Device Identifier: 08714729827658
• UDI-Public: (01)08714729827658(17)271115(10)37967278
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: M00584190
• Device Catalogue Number: M00584190
• Device Lot Number: 0037967278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/02/2026
• Date Device Manufactured: 11/15/2025
• 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 Sex: Unknown