MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUEtome 44; Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Model Number	M00584180
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	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was attempted to be used in the papilla during an endoscopic retrograde cholangiopancreatography procedure to treat stones performed on (b)(6)2026.During the procedure, the cutting wire broke when performing sphincterotomy and the wire was lodged in the tissue.It was reported that a part of the cutting wire detached and fell into the patient and was eventually retrieved by pulling on the tome.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.Note: the instructions for use (ifu) indicates that the sphincterotome does not need to be energized prior to performing sphincterotomy.Energizing the cutting wire prior to use will cause premature cutting wire fatigue and will compromise the cutting wire's integrity.However, the customer reported that the device was energized prior to bowing.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.

• Brand Name: TRUEtome 44
• 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 ; +1(914)571-6918
• MDR Report Key: 50754099
• Report Number: 3005099803-2026-03743
• Device Sequence Number: 9631499
• Product Code: KNS
• UDI-Device Identifier: 08714729827641
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: M00584180
• Device Catalogue Number: M00584180
• Device Lot Number: 0039287706
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 05/08/2026
• 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