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

Model Number	M00584190
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome 39 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat biliary stones performed on (b)(6) 2025.During the procedure, when bowing the tome the cutting wire snapped.It was reported that no part of the cutting wire detached and fell into the patient.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 fully recovered.Note: it was reported that the device was energized when not in contact with tissue; however, per the instructions for use (ifu), precaution: it is recommended to maintain direct and constant contact with tissue when applying electrocautery current.Failure to do so may result in broken cut wire, damage to the endoscope and/or patient injury.Additionally, it was also indicated that the device was energized prior to bowing; however, according to the ifu, the device does not need to be energized prior to performing sphincterotomy as energizing the cutting wire prior to use will cause premature cutting wire fatigue and will compromise the cutting wire's integrity.
Additional Manufacturer Narrative
Block e: this event was reported by the sales representative.The healthcare facility is: (b)(6).Phone number: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.

• 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: 23888521
• Report Number: 3005099803-2025-06870
• Device Sequence Number: 9650632
• Product Code: KNS
• UDI-Device Identifier: 08714729827658
• UDI-Public: (01)08714729827658(17)270822(10)37276594
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/24/2025

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: 0037276594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/24/2025
• Date Device Manufactured: 08/22/2025
• 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