MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584170
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
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 ampulla during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2026.During the procedure, the cutting wire of the truetome 44 broke.The procedure was completed with another of the same device.There were no reported patient complications as a result of this event.Note: it was reported that the exposed cutting wire was not fully exited the endoscope when the device was energized; however, according to the instructions for use (ifu), verify that the cutting wire has exited the endoscope by visualizing it on the endoscope monitor.Failure to do so may result in contact between the cutting wire and the endoscope while electrical current is applied.This may cause grounding, which can result in patient injury, operator injury, a broken cutting wire, and/or damage to the endoscope.
Additional Manufacturer Narrative
Block h2: (additional information) block b5 describe event or problem, block h6 device code have been updated based on the additional information received on april 17, 2026.Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.Block h11: (investigation result) the returned truetome 44 was analyzed, and a visual evaluation noted that the working length was twisted and the cutting wire was not broken.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break was not confirmed.Upon analysis, it was found that the working length was twisted.Based on the condition of the device, the twisted working length could be caused after multiple attempts to rotate the handle of the device or during the introduction of the device into the scope.Based on all gathered information, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of cutting wire broken.
Event or Problem Description
It was reported to boston scientific corporation that a truetome 44 was attempted to be used during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2026.During the procedure, the cutting wire of the truetome 44 broke.The procedure was completed with another of the same device.No further information has been obtained despite good faith efforts.There were no reported patient complications as a result of this event.

• 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 ; 9145716918
• MDR Report Key: 24650572
• Report Number: 3005099803-2026-01041
• Device Sequence Number: 21384315
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• UDI-Public: (01)08714729827634(17)271013(10)37688164
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: M00584170
• Device Catalogue Number: M00584170
• Device Lot Number: 0037688164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2025
• 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